StrokeNCT01468701
GLORIA-AF Registry Program - Second and Third Phases
An observational study of Stroke and Atrial Fibrillation, run by Boehringer Ingelheim at 666 sites in 21 countries.
Trial summary
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation
- How many people
- 37,235 participants
- Where
- 666 sitesin 21 countries
- Study dates
- 7 Nov 2011to 10 Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with non-valvular AF
Who may be able to join
- Age =>18 years at enrollment
- Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
- Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.
- Other inclusion criteria apply.
Who cannot join
- Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
- Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
- AF with a generally reversible cause;
- Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated Other exclusion criteria apply
Trial locations and contacts
666 sites in 21 countries.
642 sites in 21 countries
United States300 sites
Abington Medical Specialists
Abington, Pennsylvania, 19003
Albany Medical Center / Albany Medical College
Albany, New York, 12208
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108
Cambridge Medical Trials
Alexandria, Louisiana, 71301
Endeavor Medical Research
Alpena, Michigan, 49707
McFarland Clinic PC
Ames, Iowa, 50010
Alaska Heart Institute
Anchorage, Alaska, 99508
AnMed Health Clinical Research
Anderson, South Carolina, 29621
Internal Medicine Associates of Anderson, PA
Anderson, South Carolina, 29621
Cardiac Consultants, LLC
Annapolis, Maryland, 21401
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, 60005
Executive Health and Research Associates
Atlanta, Georgia, 30342
Saint Joseph's Research Institute
Atlanta, Georgia, 30342
Aurora Denver Cardiology Associates, PC
Aurora, Colorado, 80012
THV Research, LLC
Austin, Texas, 78745
Aventura Institute for Cardiovascular Wellness, PA
Aventura, Florida, 33180
Primary Care Cardiology Research, Inc
Ayer, Massachusetts, 01432
MedStar Health Research Institute
Baltimore, Maryland, 21218
Cardiovascular Research Foundation of Louisiana
Baton Rouge, Louisiana, 70808
McLaren Bay Region Medical Center
Bay City, Michigan, 48708
Lowcountry Medical Group, LLC
Beaufort, South Carolina, 29906
Southeast Texas Clinical Research Center
Beaumont, Texas, 77702
Southern Maine Health Care
Biddeford, Maine, 04005
The Center for Clinical Trials, Inc.
Biloxi, Mississippi, 39531
Grace Research, LLC
Bossier City, Louisiana, 71111
Bay Area Cardiology
Brandon, Florida, 33511
Connecticut Clinical Research, LLC
Bridgeport, Connecticut, 06606
Connecticut Heart and Vascular Center
Bridgeport, Connecticut, 06606
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Medicor Cardiology
Bridgewater, New Jersey, 08807
Genesys Research Institute, Incorporated
Brighton, Massachusetts, 02135
New York -Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Hendricks Family Medicine
Brownsburg, Indiana, 46112
Burke Internal Medicine and Research
Burke, Virginia, 22015
Kernodle Clinic West
Burlington, North Carolina, 27215
Cooper University Hospital
Camden, New Jersey, 08014
Community Cardiology
Camillus, New York, 13031
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011
Aultman Hospital
Canton, Ohio, 44710
Prairie Cardiovascular Memorial Hospital
Carbondale, Illinois, 62901
Preferred Primary Care Phys
Carnegie, Pennsylvania, 15106
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201
CAMC Clinical Trials Center
Charleston, West Virginia, 25304
University of Virginia Health System
Charlottesville, Virginia, 22908
Office of Yvonne Chester
Chattanooga, Tennessee, 37404
Cardiovascular Associates, Ltd
Chesapeake, Virginia, 23320
Captain James A. Lovell Federal Health Care Center
Chicago, Illinois, 60064
Medex Healthcare Research
Chicago, Illinois, 60602
John H. Stroger Jr. Hospital of Cook Country
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
North Shore Cardiology Consultants
Chicago, Illinois, 60631
University of Chicago
Chicago, Illinois, 60637
University of Cincinnati
Cincinnati, Ohio, 45267
Tampa Bay Medical Research
Clearwater, Florida, 33761
The MetroHealth System
Cleveland, Ohio, 44109-1998
MedStar Southern Maryland Hospital Center
Clinton, Maryland, 20735
Kootenai Heart Clinics, LLC
Coeur d'Alene, Idaho, 83814
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909
Pikes Peak Cardiology
Colorado Springs, Colorado, 80909
Cardiovascular Specialists of Central Maryland
Columbia, Maryland, 21044
South Carolina Heart Center
Columbia, South Carolina, 29204
Bassett Medical Center
Cooperstown, New York, 13326
Good Samaritan Hospital Corvallis
Corvallis, Oregon, 97330
Atlanta Heart Specialists, LLC
Cumming, Georgia, 30041
Dallas VA Medical Center
Dallas, Texas, 75216
Heartplace
Dallas, Texas, 75226
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8837
Cardiology Consultants of Danville, Inc
Danville, Virginia, 24541
William C McGarity, Jr, MD, PC
Decatur, Georgia, 30035
Seidman Clinical Trials
Delray Beach, Florida, 33484
Denver Health Medical Center
Denver, Colorado, 80204
Henry Ford Hospital K-15
Detroit, Michigan, 48202
Universal Clinical Research Associates
Doral, Florida, 33166
Central Bucks Cardiology
Doylestown, Pennsylvania, 18901
Essentia Heart and Vascular Clinic
Duluth, Minnesota, 55805
Monmouth Cardiology Associates
Eatontown, New Jersey, 07724
Central Cardiology Associates
Elizabethtown, Kentucky, 42701
Diagnamics, Inc
Encinitas, California, 92024
Physician Specialist of Northern Lancaster County Medcl Grp
Ephrata, Pennsylvania, 17522
St. Vincent Consultants in Cardiovascular Disease, LLC
Erie, Michigan, 16502
Northwestern University
Evanston, Illinois, 60208
Mercy Health Fairfield Hospital
Fairfield, Ohio, 45014
Advanced Heart Care, LLC, Medicoricum, LLC
Fairview Heights, Illinois, 62208
Cleveland Cardiovascular Research Foundation
Fairview Park, Ohio, 44126
NECCR Internal Med and Cardio
Fall River, Massachusetts, 02720
Inova Research Center
Falls Church, Virginia, 22042
Virginia Heart
Falls Church, Virginia, 22042
Lillestol Research, LLC
Fargo, North Dakota, 58103
Cardiology Consultants of East Michigan
Flint, Michigan, 48532
New York Hospital Queens
Flushing, New York, 11355
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901
Parkview Research Center
Fort Wayne, Indiana, 46845
Amir Malik Research
Fort Worth, Texas, 76104
Allianz Medical and Research Center
Fountain Valley, California, 92708
Mary Washington Hospital Research Department
Fredericksburg, Virginia, 22401
B&K Medical Research Center
Fresno, California, 93721
Cardiovascular Research of North Florida LLC
Gainesville, Florida, 32605
Phoenix Heart PLLC
Glendale, Arizona, 85306
Genesys Heart Institute
Grand Blanc, Michigan, 48439
Regional Cardiology Associates
Grand Blanc, Michigan, 48439
State of the Heart Cardiology
Grapevine, Texas, 76051
Piedmont Cardiology Associates, P.A.
Greenwood, South Carolina, 29646
Electrophysiology Associates of Northern New Jersey
Hackensack, New Jersey, 07601
Advocare Heights Primary Care
Haddon Heights, New Jersey, 08035
Heart Clinic of Hammond
Hammond, Louisiana, 70403
Associated Cardiovascular Consultants Lourdes
Hammonton, New Jersey, 08037
Harleysville Medical Associates
Harleysville, Pennsylvania, 19438
Harrisonburg Medical Associates
Harrisonburg, Virginia, 22801
American Clinical Trials
Hawaiian Gardens, California, 90716
Magi Research Clinic, Inc
Hialeah, Florida, 33013
Clinical Trials of America, Inc
Hickory, North Carolina, 28601
Carolina Cardiology Cornerstone
High Point, North Carolina, 27262
Adventist Health Partners, Inc
Hinsdale, Illinois, 60521
Global Research Solutions Corporation
Hollywood, Florida, 33021
Mercy Cinic Hot Springs Communities
Hot Springs, Arizona, 71913
Dr. Michael A. Frais, Cardiologist, P.A.
Hot Springs, Arkansas, 71913
Angiocardiac Care of Texas
Houston, Texas, 77025
Houston Methodist DeBakey Cardiology Associates
Houston, Texas, 77030
Barry Troyan, M.D, PA
Houston, Texas, 77043
Centex Studies, Inc.
Houston, Texas, 77062
Dairy Ashford Family Pratice
Houston, Texas, 77077
Emil Hayek, M.D., Inc
Hudson, Ohio, 44236
Cardiovascular Associates PLLC
Humble, Texas, 77338
University Cardiovascular Services
Huntington, West Virginia, 25701
St. Mary's Medical Center
Huntington, West Virginia, 25702
St. Vincent Medical Group
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University Of Mississippi Medical Center
Jackson, Mississippi, 39216
The Jackson Clinic, PA
Jackson, Tennessee, 38301
St. Vincent's Ambulatory Care
Jacksonville, Florida, 32216
Profen Research Network at East Carolina Medical Associates
Jacksonville, North Carolina, 28546
Lycoming Internal Medicine, Inc
Jersey Shore, Pennsylvania, 17740
UHS Office of Clinical Trials
Johnson City, New York, 13790
Center For Cardiovascular Research
Johnson City, Tennessee, 37604
Tenet Florida Physician Services
Jupiter, Florida, 33458
Kalispell Regional Medical Center
Kalispell, Montana, 59901
Kannapolis Internal Medicine
Kannapolis, North Carolina, 28083
Health Midwest Ventures Group, Inc
Kansas City, Missouri, 64132
Cardiology Center of Houston, PA
Katy, Texas, 77450
Innovation Center, Kettering Medical Center
Kettering, Ohio, 45429
Texas Cardiology Research Center PLLC
Kingwood, Texas, 77339
PMG Research of Knoxville
Knoxville, Tennessee, 37912
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, 37934
PMG Research of Knoxville
Knoxville, Tennessee, 37938
Mayo Clinic-Sparta
La Crosse, Wisconsin, 54601
Scripps Clinic
La Jolla, California, 92037
La Mesa Cardiac Center
La Mesa, California, 91942
Beacon Medical Group Clinical Research
La Porte, Indiana, 46350
Cardiovascular Specialists of Southwest Louisiana, LLC
Lake Charles, Louisiana, 70601
Midwest Internal Medicine, PLLC
Lake Havasu City, Arizona, 86403
Watson Clinic Center for Research, Inc
Lakeland, Florida, 33805
Cardiology Consultants of Philadelphia
Lansdale, Pennsylvania, 19446-3748
Thoracic and Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
Clinical Trials of America, Inc
Lenoir, North Carolina, 28645
NJ Heart LLC
Linden, New Jersey, 07036
Cardiology and Medicine Clinic
Little Rock, Arkansas, 72204
Donald W. Reynolds Institute on Aging
Little Rock, Arkansas, 72205-7199
Arkansas Cardiology, PA
Little Rock, Arkansas, 72205
South Denver Cardiology Associates, PC
Littleton, Colorado, 80120
Los Alamitos Cardiovascular
Los Alamitos, California, 90720
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
Caprock Cardiac Center Research Institute
Lubbock, Texas, 79410
Coliseum Medical Center
Macon, Georgia, 31217
Baptist Health Clinical Studies
Madisonville, Kentucky, 42431
Garden State Heart Care, PC
Manalapan, New Jersey, 07726
Manassas Clinical Research Center
Manassas, Virginia, 20110
RAS Health Ltd
Marion, Ohio, 43302
Frederick C Smith Clinic Inc
Marion, Ohio, 43342
Upper Michigan Cardiovascular Associates, PC
Marquette, Michigan, 49855
Consultants in Cardiovascular Medicine
Melrose Park, Illinois, 60160
Medpharmics, LLC
Metairie, Louisiana, 70006
A&L Clinical Research
Miami, Florida, 33126
Miami Center for Cardiovascular Disease
Miami, Florida, 33136
Global Research Solutions Corporation
Miami, Florida, 33144
Cardiovascular Research Center of South Florida
Miami, Florida, 33173
New Horizon Research Center
Miami, Florida, 33175
Mound Family Practice
Miamisburg, Ohio, 45342
Cardiovascular Associates of Virginia
Midlothian, Virginia, 23114
Karim Bakhtiar MD, SC
Milwaukee, Wisconsin, 53215
Family Medical Clinic
Milwaukee, Wisconsin, 53216
Wheaton Franciscan
Milwaukee, Wisconsin, 53221
Milwaukee VA Medical Center
Milwaukee, Wisconsin, 53295
Long Island Heart Associates
Mineola, New York, 11501
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Trinity Health Center Medical Arts
Minot, North Dakota, 58701
Sacred Heart Medical Specialty Group
Miramar Beach, Florida, 32550
University South Alabama Medical Center
Mobile, Alabama, 38817
Koch Family Medicine
Morton, Illinois, 61550
McLaren-Macomb
Mount Clemens, Michigan, 48043
Office of Dr. Paul McLaughlin, M.D.
Mount Sterling, Kentucky, 40353
Cardiology Associates of Northwest Indiana, PC
Munster, Indiana, 46321
Family Medicine of SayeBrook
Myrtle Beach, South Carolina, 29588
Collier HMA Physician Management
Naples, Florida, 34119
Atlantic Cardiology, LLC
Neptune City, New Jersey, 07753
Mission Research Institute, LLC
New Braunfels, Texas, 78130
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
LSU Health Sciences Center
New Orleans, Louisiana, 70112
Edgewater Medical Research
New Smyrna Beach, Florida, 32169
Chinatown Cardiology, PC
New York, New York, 10013
Lenox Hill Hospital
New York, New York, 10021
Saint Luke - Roosevelt Hospital Center
New York, New York, 10025
Red Clay Research LLC.
Newark, Delaware, 19713
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
South Western Medical Clinic
Niles, Michigan, 49120
Black Warrior Research
Northport, Alabama, 35476
Mehrdad Kevin Ariani, MD, Incorporated
Northridge, California, 91325
Cardiology Associates of Fairfield County
Norwalk, Connecticut, 06851
Norwalk Medical Group
Norwalk, Connecticut, 06851
Providence Park Hospital
Novi, Michigan, 48374
SouthEast Medical Centre
Oakland Park, Florida, 33309
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120
MidAmerica Cardiovascular Institute
Omaha, Nebraska, 68131
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
Board of Regents of the University of Nebraska
Omaha, Nebraska, 68198-7835
Research One
Orlando, Florida, 32806
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211
Research Integrity, LLC
Owensboro, Kentucky, 42303
VA Palo Alto Health Care System
Palo Alto, California, 94304
Alegent Health Heart and Vascular Specialists
Papillion, Nebraska, 68046
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Memorial Hospital of RI
Pawtucket, Rhode Island, 02860
South Florida Research Solutions, LLC
Pembroke Pines, Florida, 33028
Langhorne Cardiology Consultants, Inc
Pensacola, Florida, 32501
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6205
Pennsylvania Cardiology Associates
Philadelphia, Pennsylvania, 19106
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, 19141
Pinehurst Medical Clinic, Inc
Pinehurst, North Carolina, 28374
Allegheny Neurology Associates
Pittsburgh, Pennsylvania, 15212
VNH Heart Center Research
Port Charlotte, Florida, 33952
Sound Medical Research
Port Orchard, Washington, 98366
Fanno Creek Clinic, LLC
Portland, Oregon, 97219
Wake Heart Research
Raleigh, North Carolina, 27610
Eisenhower Desert Cardiology Center
Rancho Mirage, California, 92270
Black Hills Cardiovascular Research
Rapid City, South Dakota, 57701
Renown Institute for Heart and Vascular Health
Reno, Nevada, 89502
VA Sierra Nevada Health Care System
Reno, Nevada, 89502
CJW Medical Center - Chippenham
Richmond, Virginia, 23225
The Valley Hospital
Ridgewood, New Jersey, 07450
Carilion Clinic
Roanoke, Virginia, 24014
Advanced Cardiovascular Consultants
Rock Island, Illinois, 61201
Brevard Cardiovascular Research Associates, Inc
Rockledge, Florida, 32955
Covenant Medical Center, Inc.
Saginaw, Michigan, 48602
MId-MIchigan Heart and Vascular Center
Saginaw, Michigan, 48604
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, 56303
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102
Salem VA Medical Center
Salem, Virginia, 24153
Delmarva Heart Research Foundation, Inc
Salisbury, Maryland, 21804
Peninsula Cardiology Associates
Salisbury, Maryland, 21804
Heart Center at Saint Mark's
Salt Lake City, Utah, 84124
Highland Clinical Research
Salt Lake City, Utah, 84124
Mercury Medical ,LLC
San Antonio, Texas, 78229
Texas Medical Research Associates
San Antonio, Texas, 78238
Ritchken and First MD's
San Diego, California, 92117
Coastal Heart Group Inc
Santa Ana, California, 92704
Velella Research, Inc
Sarasota, Florida, 34233
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239
Saratoga Clinical Research, LLC
Saratoga Springs, New York, 12866
Scottsboro Quick Care Clinic
Scottsboro, Alabama, 35768
Sealy Urgent Care Center and Medical Clinic
Sealy, Texas, 77474
The Polyclinic
Seattle, Washington, 98133
Seguin Institute of Cardiovascular Research
Seguin, Texas, 78155
Grand View - Lehigh Valley Health Services
Sellersville, Pennsylvania, 18960
James C. Neiman, MD
Seminole, Florida, 33772
Heart Specialists, PC of Southern CT
Shelton, Connecticut, 06484
Advanced Cardiovascular Specialists
Shreveport, Louisiana, 71103
Louisiana Heart Center
Slidell, Louisiana, 70458
Heart and Vascular Center of New Brunswick
Somerset, New Jersey, 08873
Beacon Medical Group Clinical Research
South Bend, Indiana, 46601
Central New Jersey Cardiology
South Plainfield, New Jersey, 07080
Heart House Research Foundation, LLC
Springfield, Ohio, 45504
Sacred Heart Medical Center at RiverBend
Springfield, Oregon, 97477
Saint Louis University
St Louis, Missouri, 63110
Consult and Research Associates
St Louis, Missouri, 63122
Gateway Cardiology, PC
St Louis, Missouri, 63128
Suncoast Cardiovascular Research Inc.
St. Petersburg, Florida, 33701
Northside Hospital
St. Petersburg, Florida, 33709
Alternative Solutions Medical Research and Prevention Center
St. Petersburg, Florida, 33711
Pacific Heart and Vascular
Stockton, California, 95210
Stony Brook Cardiology/Electrophysiology
Stony Brook, New York, 11794-8167
Sugarland Cardiology
Sugar Land, Texas, 77479
SUNY Upstate Medical University
Syracuse, New York, 13202
New York Heart Center
Syracuse, New York, 13210
Franciscan Heart and Vascular Associates
Tacoma, Washington, 98405
Tallahassee Research Instutite
Tallahassee, Florida, 32308
University of South Florida
Tampa, Florida, 33606
Southwest Heart Institute
Temecula, California, 92591
Cardiac Care and Vascular Medicine, PLLC
The Bronx, New York, 10469
Cardiovascular Research Center
Toledo, Ohio, 43608
Toledo Clinic Incorporated
Toledo, Ohio, 43623
University of California Los Angeles
Torrance, California, 90509
Chesapeake Cardiovascular Associates
Towson, Maryland, 21204
Cardiovascular Associates of East Texas, PA
Tyler, Texas, 75701
Trinity Clinic
Tyler, Texas, 75702
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
Cardiology Associates Medical Group Inc
Ventura, California, 93003
Ventura Cardiology Consultants Medical Group, Inc
Ventura, California, 93003
Ventura Clinical Trials
Ventura, California, 93003
Indian River Medical Associates Cardiology
Vero Beach, Florida, 32960
China59 sites
Beijing AnZhen Hospital
Beijing, 100029
Peking University First Hospital
Beijing, 100034
Cardiovascular Institute and Fu Wai Hospital
Beijing, 100037
Beijing Shijingshan Hospital
Beijing, 100043
Beijing Tsinghua Changgung Hospital
Beijing, 100044
Peking Union Medical College Hospital
Beijing, 100730
First Hospital of Jilin University
Changchun, 130021
Xiangya Hospital, Central South University
Changsha, 410008
2nd Xiangya Hospital of Central South University
Changsha, 410011
Chinese Traditional Medicine Hospital of Sichuna Provinc
Chengdu, 610000
Center Hospital of Dalian
Dalian, 116033
Foshan Hospital of Southern Medical University
Foshan, 528000
Fujian Provincal Hospital
Fuzhou, 350001
Guangdong Provincial People's Hospital
Guangzhou, 510080
The First Afiliated Hospital, Sun Yet-sen University
Guangzhou, 510080
Wu Jing Zong Dui Hospital of Guangdong Province
Guangzhou, 510507
The First Affiliated Hospital of Jinan University
Guangzhou, 510630
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, 310000
Hangzhou First People's Hospital
Hangzhou, 310006
Shandong Jiaotong Hospital
Jinan, 250000
Center Hospital of Jinan
Jinan, 250013
Qianfoshan Hospital affiliated to Shandong University
Jinan, 250014
Shandong Provincial Hospital
Jinan, 250021
Jining No.1 people's hospital
Jining, 272111
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006
Zhongda Hospital Southeast University
Nanjing, 210009
The affiliated hospital of medicalcollege qingdao university
Qingdao, 266003
QingDao Municipal Hospital
Qingdao, 266011
Qingdao Fuwai Hospital
Qingdao, 266034
Qingdao Central Hospital
Qingdao, 266042
Chinese People's Liberation Army 401 Hospital
Qingdao, 266071
Huashan Hospital, Fudan University
Shanghai, 200040
Shanghai Huadong Hospital
Shanghai, 200040
Tongji Hospital, Tongji University
Shanghai, 200065
Shanghai East Hospital, Tongji University China
Shanghai, 200120
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
Shanghai, 200127
Minhang District Central Hospital
Shanghai, 201199
Songjiang Hospital
Shanghai, 201600
Jiading Hospital
Shanghai, 201800
Shengjing Hospital of China Medical University
Shenyang, 110004
General Hospital of Shenyang Military Region
Shenyang, 110015
People's Hospital of Liaoning Province
Shenyang, 110016
The Forth People's Hospital of Shenzhen
Shenzhen, 518033
The Second Hospital of Hebei Medical University
Shijiazhuang, 050000
Hebei Provincial Tumor Hospital
Shijiazhuang, 050011
SuZhou Kowloon Hospital
Suzhou, 215021
The Central Hospital of Tai'an
Tai’an, 250001
Shanxi Cardiovascular Hospital
Taiyuan, 030024
Wu Jing Yi Xue Yuan Fu Shu Yi Yuan
Tianjin, 300162
Wuhan Asia Heart Hospital
Wuhan, 430022
Hubei Province Zhongshan Hospital
Wuhan, 430032
First Affiliated Hospital of Xiamen University
Xiamen, 361003
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, 361004
Xuzhou Central Hospital
Xuzhou, 221009
Subei People's Hospital
Yangzhou, 225001
zhengzhou No.7 people's Hospital
Zhengzhou, 450006
Zhengzhou Central Hospital
Zhengzhou, 450007
Zhengzhou People'S Hospital
Zhengzhou, 450012
Yankuang Group General Hospital
Zoucheng, 273500
Japan44 sites
Asahi General Hospital
Chiba, Asahi, 289-2511
Seikeikai New Tokyo Heart Clinic
Chiba, Matsudo, 271-0077
Saiseikai Matsuyama Hospital
Ehime, Matsuyama, 791-8026
Fukuiken Saiseikai Hospital
Fukui, Fukui, 918-8503
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, 815-8555
Aso Co.,Ltd Iizuka Hospital
Fukuoka, Iizuka, 820-8505
Nakamura Cardiovascular Clinic
Fukuoka, Itoshima, 819-1104
Fukuoka Tokushukai Medical Center
Fukuoka, Kasuga, 816-0864
Shin Komonji Hospital
Fukuoka, Kitakyushu, 800-0057
Fukuoka Shin Mizumaki Hospital
Fukuoka, Onga, 807-0051
Matsuda Cardiovascular Clinic
Hokkaido, Sapporo, 003-0026
Kobe City Medical Center General Hospital
Hyogo, Kobe, 650-0047
Higashi Takarazuka Satoh Hospital
Hyogo, Takarazuka, 665-0873
Houju Memorial Hospital
Isikawa, Nomi, 923-1226
KKR Takamatsu Hospital
Kagawa , Takamatsu, 760-0018
Kagawa Prefectural Shirotori Hospital
Kagawa, Higashikagawa, 769-2788
Kokan Clinic
Kanagawa, Kawasaki, 210-0852
Sekishinkai Kawasaki Saiwai Clinic
Kanagawa, Kawasaki, 212-0016
Sagamihara Kyodo Hospital
Kanagawa, Sagamihara, 252-5188
Social Medical Corporation Chikamorikai Chikamori Hospital
Kochi, Kochi, 780-8522
Nakayama Clinic of I.M. and Cardiology, Kochi, Cardiology
Kochi, Kochi, 781-5106
Sugimurakai Medical Association Sugimura Hospital
Kumamoto, Kumamoto, 860-0811
Japan Community Health care Organization Kumamoto General Hospital
Kumamoto, Yatsushiro, 866-8660
Uji-Tokushukai Medical Center
Kyoto, Uji, 611-0041
Iida Municipal Hospital
Nagano, Iida, 395-8502
Suwa Red Cross Hospital
Nagano, Suwa, 392-8510
Tachikawa General Hospital
Niigata, Nagaoka, 940-8621
Nozaki Tokushukai Hospital
Osaka, Daito, 574-0074
Teramoto Memorial Hospital
Osaka, Kawachinagano, 586-0017
Matsubara Tokushukai Hospital
Osaka, Matsubara, 580-0032
Osaka Saiseikai Nakatsu Hospital
Osaka, Osaka, 530-0012
Kitano Hospital
Osaka, Osaka, 530-8480
Osaka Kaisei Hospital
Osaka, Osaka, 532-0003
Ishinkai General Clinics
Osaka, Yao, 581-0036
Medical corporation Chisei-kai Watanabe clinic
Saitama, Okegawa, 363-0022
SAINO Clinic
Saitama, Tokorozawa, 359-1141
Kusatsu Heart Center
Shiga, Kusatsu, 525-0014
Shizuoka Tokushukai Hospital
Shizuoka, Shizuoka, 421-0193
The Institute for Adult Deseases, Asahi Life Foundation
Tokyo, Chuo-ku, 103-0002
Minamino Heart Clinic
Tokyo, Hachioji, 192-0918
Shimizu Clinic
Tokyo, Kodaira, 187-0003
The Cardiovascular Institute Hospital
Tokyo, Minato-ku, 106-0031
YOGA Urban Clinic
Tokyo, Setagaya, 158-0097
The University of Toyama Hospital
Toyama, Toyama, 930-0194
Canada37 sites
Antigonish Medical Associates Inc.
Antigonish Nova Scotia, Nova Scotia, B2G 2C7
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Cambridge Cardiac Care Inc.
Cambridge, Ontario, N1R 6V6
Q & T Research Chicoutimi Inc
Chicoutimi, Migration Data, G7H 7Y8
North Road Clinical Research
Coquitlam, British Columbia, V3K 3V9
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 2B7
West Lincoln Memorial Hospital
Grimsby, Ontario, L3M 1P3
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Winterberry Family Medicine
Hamilton, Ontario, L8J 0B6
Hamilton Medical Research Group
Hamilton, Ontario, L8M 1K7
Hamilton General Hospital
Hamilton, Ontario, L8S 4T1
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1E4
Clinique de Cardiologie de Levis
Lévis, Quebec, G6V 4Z5
Victoria Hospital (LHSC)
London, Ontario, N6A 5A5
Mississauga Clinical Research Centre
Mississauga, Ontario, L5B 2P7
CHUM Hotel Dieu
Montreal, Quebec, H2W 1T8
SKDS Research Incorporated
Newmarket, Ontario, L3Y 5G8
M Heffernan Medicine Professional Corp.
Oakville, Ontario, L6K 3W7
Oshawa Clinic Cardiology Department, Oshawa, Courtice
Oshawa, Ontario, L1H 1B9
Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9
University of Ottawa Heart Institute Cardiology Research
Ottawa, Ontario, K1Y 4W7
Recherche Clinique Sigma Inc.
Québec, Quebec, G1G 3Y8
Crestwood Med & Dental Bldg
Richmond, British Columbia, V7C 3V3
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
IUCPQ (Laval University)
Sainte-Foy, Quebec, G1V 4G5
Baycole Research
Saskatoon, Saskatchewan, S7L 2W1
CHUS Fleurimont
Sherbrooke, Quebec, J1H 5N4
CardioVasc HR Inc.
St-Jean-sur-Richel, Migration Data, J3A 1C3
Eastern Health (MUN)
St. John's, Newfoundland and Labrador, A1B 3V6
Aviva Clinical Trial Group Inc.
Stoney Creek, Ontario, L8J 2V8
Ocean West Research Clinic Inc.
Surrey, British Columbia, V3S 2N6
SGH Medical Mall
Toronto, Ontario, M1P 2T7
Keele Medical Place
Toronto, Ontario, M3M 3E5
Toronto General Hospital
Toronto, Ontario, M4G 2C4
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Victoria Cardiac Arrhythmia Trials Inc.
Victoria, British Columbia, V8T 1Z4
South Korea31 sites
Sejong General Hospital
Bucheon-si, 14754
Dong-A University Hospital
Busan, 49201
Kosin University Gospel Hospital
Busan, 602-702
Pusan National Univ. Hosp
Busan, 602-739
Inje University Haeundae Paik Hospital
Busan, 612-896
Inje University Busan Paik Hospital
Busan, 614-735
Keimyung University Dongsan Medical Center
Daegu, 41931
Kyungpook National Univ. Hosp
Daegu, 700-721
Daegu Fatima Hospital
Daegu, 701-724
Yeungnam University Medical Center
Daegu, 705-703
The Catholic University of Korea, Daejeon St.Mary's Hospital
Daejeon, 301-723
Eulji University Hospital
Daejeon, 302-799
Chonnam National University Hospital
Gwangju, 501-757
Wonkwang University Hospital
Iksan, 54538
Jeju National University Hospital
Jeju City, 63241
Chonbuk National University Hospital
Jeonju, 54907
Gyeongsang National University Hospital
Jinju, 52727
Seoul National University Bundang Hospital
Seongnam, 13620
Kyung Hee University Medical Center
Seoul, 02447
Korea University Anam Hospital
Seoul, 02841
Kangdong Sacred Heart Hospital
Seoul, 05355
VHS Medical Center
Seoul, 05368
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 06591
Seoul National University Hospital
Seoul, 110-744
Severance Hospital
Seoul, 120-752
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 130-709
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul, 138-736
Ajou University Hospital
Suwon, 16499
Ulsan University Hospital
Ulsan, 682-714
Pusan National University Yangsan Hospital
Yangsan, 626-770
Brazil30 sites
Hospital Vera Cruz
Belo Horizonte, 30140-092
Clinica Procardio Ltda
Blumenau, 89010-500
Hospital do Coracao do Brasil
Brasília, 70390-903
Instituto de Cardiologia do Distrito Federal
Brasília, 70658-700
Hospital Angelina Caron
Campina Grande do Sul, 83430-000
Centro Especializado em Cardiol Loema Instituto de Pesq Clin
Campinas, 13010-001
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
Campinas, 13060-904
Hospital Nossa Senhora de Pompeia
Caxias do Sul, 95084-900
Irmandade da Santa Casa de Misericordia de Curitiba
Curitiba, 80010-030
Barroso e Sebba Ltda
Goiânia, 74223-130
CLINICOR-Clinica de Exames Cardiolog e Ecografias S S LTDA
Maceió, 57051-500
Hospital São Vicente de Paulo
Passo Fundo, 99010-080
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903
Fundacao Universitaria de Cardiologia - Inst de Cardiologia
Porto Alegre, 90620-001
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares
Recife, 50100-130
Hospital Copa D'or
Rio de Janeiro, 22031-011
Fundacao Pro-Coracao FUNDACOR
Rio de Janeiro, 22240-004
Instituto Cardiopulmonar da Bahia LTDA
Salvador, 40170-130
Fundacao Bahiana de Cardiologia
Salvador, 41810-010
Instituto de Ensino E Pesquisa Do Hospital Da Bahia
Salvador, 41810-011
Instituto de Molestias Cardiovasculares - IMC
São José do Rio Preto, 15015-210
H.S.J. Beneficência Portuguesa - São Paulo
São Paulo, 01323-001
FGM - Clínica Paulista de Doenças Cardiovasculares
São Paulo, 01327-010
Hcor - Hospital do Coracao
São Paulo, 04004-030
Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012-180
Hospital das Clinicas da Faculdade de Medicina - FMUSP
São Paulo, 05403-000
Hospital Santa Marcelina
São Paulo, 08270-070
Hospital Sao Paulo UNIFESP
São Paulo, 4038-031
Instituto de Molestias Cardiovasculares Tatui SP
Tatuí, 18270-170
Santa Casa de Votuporanga
Votuporanga, 15500-003
Russia25 sites
Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul
Barnaul, 656055
Chelyabinsk State Med.Acad, Dept. of Clinical Pharmacology
Chelyabinsk, 454092
Chita State Med.Acad, Consultative-Diagnostic-Polyclinic
Chita, 672090
OJSC Municipal Instit.Dzerjinskiy City Hospital
Dzerjinskiy, 140 091
Road Clin.Hosp.Irkutsk-Russian Railways,Cardio.&Therapy Dept
Irkutsk, 664005
City Clin.Hosp.#9,Intern.Diseases&Fam.Practice Dept, Izhevsk
Izhevsk, 426063
Res.Inst.-Compl.Iss.Cardi.Dis.
Kemerovo, 650002
Municipal Instit. City Hosp. No.2, Policlinic Dept,Krasnodar
Krasnodar, 350 012
GOU VPO MUZ City Clinical Hospital No. 20, Krasnoyarsk
Krasnoyarsk, 660014
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
Moscow, 119992
Research Center n.a.A.N.Bakulev,Clin.-Diagnostic Dept,Moscow
Moscow, 121552
Russian Cardiology Research and Production Complex, Moscow
Moscow, 121552
Reg.Clin.Cardiological Dispen,Arrhythmology Dept,Novosibirsk
Novosibirsk, 630047
Omsk State Medical Acad.,Internal Diseases&Fam.Practice Dept
Omsk, 644043
Orenburg State Medical Academy of MoH, Therapy Department
Orenburg, 460 000
Instit.Healthcare,MedicalSanitary Unit 9,n.a.M.A.Tverie,Perm
Perm, 614990
Rostov Regional Clinical Hospital
Rostov-on-Don, 344015
Ryazan Reg.Clin.Hosp.Internal Diseases&Policlin.Therapy Dept
Ryazan, 390039
Fed.Centre of Heart, Blood & Endocrinology n.a. V.A. Almazov
Saint Petersburg, 197341
Pokrovskaya City Hospital, St.Petersburg
Saint Petersburg, 199106
Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept.
Samara, 443070
Samara State Medical University, Chair of Faculty Therapy
Samara, 443099
Municipal Instit.Healthcare,City Policlinic #6,Therapy Dept.
Saratov, 410015
Primorskiy Regional Clinical Hospital No. 1
Vladivostok, 690091
GBUZ SO Ural Institute of Cardiology, Ekaterinburg
Yekaterinburg, 620 144
Mexico23 sites
Hospital General de Acapulco
Acapulco de Juárez, Guerrero, 39570
Hospital Cardiologica Aguascalientes
Aguascalientes, 20230
Christius Muguerza Hospital del Parque
Chihuahua City, 31020
Centro Especializado de Investigación Medical Group Culiacan
Culiacán, 80200
Centro para el Desarrollo de la Medicina y de Asist Med Espe
Culiacán, 80230
Instituto Nacional de Cardiologia Ignacio Chavez
Distrito Federal, 14080
Unidad Coronariana del Hospital General de Durango
Durango, 34000
Centro de Investigación Especializada de Occidente S.C.
Guadalajara, 44160
Clínica de Estudios Médicos S.C.
Guadalajara, 44600
ICLE SC
Guadalajara, 44600
Private Practice
Guadalajara, 44670
Centro Medico de las Americas
Mérida, Yucatán, 97000
Paracelsus S. A. de C.V.
México, 03800
Hospital Metropolitano "Dr Bernardo Sepulveda"
Monterrey, 66480
Clinica Miravalle
Monterrey, Nuevo Leon, 64000
Unidad de Investigacion Clinica en Medicina, S.C.
Monterrrey, 64718
Consultorio Privado J Arturo Maldonado Villalon
Morelia, Michoacan, 58260
Clinical Medical Research S.C
Orizaba, 94300
Instituto de Corazón de Querétaro
Querétaro, 76000
Cardioarritmias e Investigación S.C
San Luis Potosí City, 78200
Plaza Medical
Tijuana, 22320
Servicios Diagnosticos en Medicina SC
Toluca, Estado de Mexico, 52140
iBiomed
Zapopan, 45030
Argentina16 sites
Consultorios Hematologicos SRL
Buenos Aires, 1188
Clinica Coronel Suárez
Buenos Aires, B7540GHD
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH
Instituto Cardiovascular de Buenos Aires
Buenos Aires, C1428
Instituto Cardiovascular de Corrientes Juana Francisca Cabra
Corrientes, C3400
Hospital Espanol de Mendonza
Godoy Cruz, 5501
Hospital Privado de Comunidad
Mar del Plata, 7602
DIM Clinica Privada
Ramos Mejía, B1704ETD
Hospital Privado de Rosario
Rosario, S2000GAP
Consultorio del Dr. Aiub
San Isidro, 1642
Sanatorio San Lucas
San Isidro, B1642DJG
Sanatorio 9 de Julio S.A.
San Miguel de Tucumán, 4000
Centro Privado de Cardiología
San Miguel de Tucumán, T4000NIL
Unidad Coronaria San Geronimo S.R.L.
Santa Fe, 3000
Clinical Juncal
Temperley, 1834
CEMEDIC - Centro de Especialidades Medicas
Villa Luro, 1407
Colombia12 sites
Fundacion Hospital Infantil Universitario de San José
Bogotá, 111221
Fundacion Clinica Shaio
Bogotá
Simedics Ips
Bogotá
Hospital Santa Clara E.S.E.
Bogota DC
Fundacion Valle de Lilly
Cali
Centro Médico Julián Coronel
Cali -Valle Del Cauca
Centro de Diagnostico Cardilogico
Cartagena
Fundacion Cardiovascular de Colombia
Floridablanca, 68004
Asociacion IPS Medicos Internistas de Caldas
Manizales
Ciclam Sas
Medellín, 5001000
Ces Cardiología
Medellín
Fundacion Cardiomet Centro de Investigaciones CEQUIN
Quindío
Peru11 sites
Centro Medico Monte Carmelo
Arequipa, 054
Hospital Nacional Daniel Alcides Carrion
Bellavista, Callao 2
EsSalud - Hospital Nacional IV Alberto Sabogal Sologuren
Callao, C2
Hospital Nacional Guillermo Almenara Irigoyen
La Victoria, Lima-13
Hospital Nacional Edgardo Rebaglini Martins
Lima, Lima-11
Clinica San Pablo
Lima, Lima-33
Centro de Investigación en Diabetes, Obesidad y Nutrición
Lince, Lima-14
Clinica Internacional
San Borja, LIMA 41
Clinica Vesalio
San Borja, lima-41
Clinica El Golf
San Isidro, Lima-27
Clinica Medica Cayetano Heredia
San Martín de Porres, Lima-31
Lebanon10 sites
St.Charles Hospital
Baabda, 50 Baabda
Makassed General Hospital
Beirut, 11-6301
St. Georges Hospital
Beirut, 166 378
Hotel Dieu de France Hospital
Beirut, 166830
Rafik Hariri University Hospital
Beirut, 5244
Al Rassoul Hospital, Beirut Cardiac Institute
Beirut
American University of Beirut Medical Center
Beirut
Bellvue Medical Center, Beirut
Beirut
Notre Dame de Secours Hospital
Byblos, 3
Hammoud Hospital University Medical Center
Saida, 652
Taiwan10 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taichung Veterans General Hospital
Taichung, 407
NCKUH
Tainan, 704
National Taiwan University Hospital
Taipei, 10002
Mackay Memorial Hospital
Taipei, 10449
Cathay General Hospital
Taipei, 106
Taipei Veterans General Hospital
Taipei, 11217
Cheng Hsin General Hospital
Taipei, 11220
Chang Gung Memorial Hospital(Linkou)
Taoyuan, 330
Saudi Arabia8 sites
King Fahad Military Hospital
Dammam, 9862
King Fahad Hufuf Hospital
Hofuf, 36441
Khamis Military Hospital
Jeddah, 21424
King Abdul Aziz University Hospital
Jeddah, 22254
Prince Salman Heart Center
Riyadh, 11525
King Salman Hospital
Riyadh, 11536
King Faisal Hospital
Ta'if, 21944
Tabuk Military Hospital
Tabuk, 71411
Chile6 sites
Hospital Clínico Fuerza Aérea de Chile
Santiago, 7560171
Centro de Estudios Clinicos Barros Luco
Santiago, 8910131
Hospital y CRS El Pino
Santiago
CECMI Ltda
Temuco, 4813299
CINVEC - Centro de Investigacion Clinica V Reg.,Vina del Mar
Viña del Mar, 2520997
Clinica Tabancura
Vitacura, 7650018
South Africa5 sites
Dr. N. Ranjith
Durban, 4052
Dr Mahesh Duki Research and Trial Site
Durban, 4339
LCS Clinical Research Unit
Johannesburg, 2021
Helderberg Research Institute
Somerset West, Cape Town, 7130
Dr. Moodley and Dr. Sarvan
Tongaat, 4400
Singapore4 sites
National University Hospital
Singapore, 119074
National Heart Center
Singapore, 169609
Novena Heart Centre
Singapore, 307506
National Neuroscience Institute
Singapore, 308433
United Arab Emirates4 sites
Al Ain Hospital
Abu Dhabi, 1006
Sheikh Khalifa Medical City
Abu Dhabi, 51900
Dubai Hospital
Dubai, 7272
Al Qassimi Hospital
Sharjah city, PO BOX 2804
Ecuador3 sites
Hospital Teodoro Maldonado Carbo
Guayaquil, 190150
Unicormed SA
Guayaquil
Hospital INTERVASCU
Quito, 170122
Hong Kong3 sites
Princess Margaret Hospital
Hong Kong, 0
Queen Mary Hospital
Hong Kong, 0
Prince of Wales Hospital
Hong Kong, 999077
Venezuela1 site
Instituto de Clinicas y Urologia Tamanaco
San Roman Caracas, 1060
About this study
Official title: GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.
- Conditions
- Stroke, Atrial Fibrillation
- Medical subject headings
- Stroke, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Measured: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Measured: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Stroke or Systemic Embolism - Phase III
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Stroke - Phase II
Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Measured: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Stroke - Phase III
Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II
Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Measured: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Systemic Embolism (SE) - Phase II
Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Measured: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Systemic Embolism (SE) - Phase III
Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Pulmonary Embolism (PE) - Phase II
Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Measured: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Pulmonary Embolism (PE) - Phase III
Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Major Bleeding Events (MBE) - Phase II
Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Measured: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Major Bleeding Events (MBE) - Phase III
Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Life-threatening Bleeding Events - Phase II
Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Measured: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Life-threatening Bleeding Events - Phase III
Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Myocardial Infarction (MI) - Phase II
Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Measured: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Myocardial Infarction (MI) - Phase III
Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of All-cause Death - Phase II
Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Measured: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of All-cause Death - Phase III
Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Vascular Death - Phase II
Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Measured: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Vascular Death - Phase III
Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Measured: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study start7 Nov 2011
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468701
- Sponsor's protocol ID
- 1160.129
- Status last verified
- Mar 2021
- First submitted
- 28 Oct 2011
- Last updated
- 29 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Joddrell M, El-Bouri W, Harrison SL, Huisman MV, Lip GYH, Zheng Y; GLORIA-AFinvestigators. Machine learning for outcome prediction in patients with non-valvular atrial fibrillation from the GLORIA-AF registry. Sci Rep. 2024 Nov 7;14(1):27088. doi: 10.1038/s41598-024-78120-z.
PubMed 39511367Bergler-Klein J, Gotcheva N, Kalejs O, Kalarus Z, Kovacic D, Persic V, Shlyakhto E, Uuetoa T, Huisman MV, Lip GYH, Vinereanu D; GLORIA-AF Investigators. Antithrombotic Usage, Including Three-Year Outcomes With Dabigatran and Vitamin K Antagonists for Atrial Fibrillation, in Eastern Europe: A Descriptive Analysis From Phase 3 of the GLORIA-AF Registry. Am J Ther. 2024 Jan-Feb 01;31(1):e1-e12. doi: 10.1097/MJT.0000000000001655. Epub 2023 Jan 10.
PubMed 38231576Romiti GF, Corica B, Proietti M, Mei DA, Frydenlund J, Bisson A, Boriani G, Olshansky B, Chan YH, Huisman MV, Chao TF, Lip GYH; GLORIA-AF Investigators. Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry. EClinicalMedicine. 2023 Aug 25;63:102039. doi: 10.1016/j.eclinm.2023.102039. eCollection 2023 Sep.
PubMed 37753446Ding WY, Fawzy AM, Romiti GF, Proietti M, Pastori D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Validating the predictive ability of the 2MACE score for major adverse cardiovascular events in patients with atrial fibrillation: results from phase II/III of the GLORIA-AF registry. J Thromb Thrombolysis. 2024 Jan;57(1):39-49. doi: 10.1007/s11239-023-02866-y. Epub 2023 Aug 11.
PubMed 37566295Liu X, Feng G, Marler SV, Huisman MV, Lip GYH, Ma C. Real world time trends in antithrombotic treatment for newly diagnosed atrial fibrillation in China: reports from the GLORIA-AF Phase III registry : Trends in antithrombotic therapy use in China. Thromb J. 2023 Aug 1;21(1):83. doi: 10.1186/s12959-023-00527-x.
PubMed 37528405Ding WY, Lane DA, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Incidence and Risk Factors for Residual Adverse Events Despite Anticoagulation in Atrial Fibrillation: Results From Phase II/III of the GLORIA-AF Registry. J Am Heart Assoc. 2022 Aug 2;11(15):e026410. doi: 10.1161/JAHA.122.026410. Epub 2022 Jul 25.
PubMed 35876418Ding WY, Calvert P, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Impact of early ablation of atrial fibrillation on long-term outcomes: results from phase II/III of the GLORIA-AF registry. Clin Res Cardiol. 2022 Sep;111(9):1057-1068. doi: 10.1007/s00392-022-02022-1. Epub 2022 Apr 29.
PubMed 35488127Lip GYH, Kotalczyk A, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Marler S, Gurusamy VK, Huisman MV; GLORIA-AF Investigators. Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry. Clin Res Cardiol. 2022 May;111(5):560-573. doi: 10.1007/s00392-022-01996-2. Epub 2022 Mar 16.
PubMed 35294625Huisman MV, Teutsch C, Lu S, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Lohmann R, Gurusamy VK, Bartels DB, Lip GYH; GLORIA-AF Investigators. Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry. Clin Res Cardiol. 2022 May;111(5):548-559. doi: 10.1007/s00392-021-01957-1. Epub 2022 Mar 16.
PubMed 35294623Bayer V, Kotalczyk A, Kea B, Teutsch C, Larsen P, Button D, Huisman MV, Lip GYH, Olshansky B. Global Oral Anticoagulation Use Varies by Region in Patients With Recent Diagnosis of Atrial Fibrillation: The GLORIA-AF Phase III Registry. J Am Heart Assoc. 2022 Mar 15;11(6):e023907. doi: 10.1161/JAHA.121.023907. Epub 2022 Mar 4.
PubMed 35243870Lopez-Sendon JL, Alonso-Rodriguez D, Baron-Esquivias G, Cosin-Sales J, Marin F, Galera-Llorca J, Jimenez N, Marler S, Huisman MV, Lip GYH; Spanish GLORIA-AF investigators. Gender differences in antithrombotic treatment in patients with atrial fibrillation from Spain versus the rest of Western Europe. GLORIA-AF Program. Med Clin (Barc). 2022 Aug 26;159(4):177-182. doi: 10.1016/j.medcli.2021.09.016. Epub 2021 Dec 8. English, Spanish.
PubMed 34895750Ntaios G, Huisman MV, Diener HC, Halperin JL, Teutsch C, Marler S, Gurusamy VK, Thompson M, Lip GYH, Olshansky B; GLORIA-AF Investigators. Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry. Hellenic J Cardiol. 2021 Mar-Apr;62(2):152-157. doi: 10.1016/j.hjc.2020.11.009. Epub 2020 Dec 15.
PubMed 33338644Mazurek M, Halperin JL, Huisman MV, Diener HC, Dubner SJ, Ma CS, Rothman KJ, Healey JS, Teutsch C, Paquette M, Franca LR, Lu S, Bartels DB, Lip GYH. Antithrombotic treatment for newly diagnosed atrial fibrillation in relation to patient age: the GLORIA-AF registry programme. Europace. 2020 Jan 1;22(1):47-57. doi: 10.1093/europace/euz278.
PubMed 31651951Mazurek M, Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Zint K, Franca LR, Lu S, Lip GYH; GLORIA-AF Investigators. Gender Differences in Antithrombotic Treatment for Newly Diagnosed Atrial Fibrillation: The GLORIA-AF Registry Program. Am J Med. 2018 Aug;131(8):945-955.e3. doi: 10.1016/j.amjmed.2018.03.024. Epub 2018 Apr 11.
PubMed 29654720Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Lu S, Bartels DB, Lip GYH; GLORIA-AF Investigators. Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry. Am Heart J. 2018 Apr;198:55-63. doi: 10.1016/j.ahj.2017.08.018. Epub 2017 Aug 31.
PubMed 29653649
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)
- ClinicalTrials.gov ID
- NCT01468701
- Acronym / sponsor ID
- 1160.129
- Conditions
- Stroke, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37,235 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2011 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Posted 29 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with non-valvular AF
Key inclusion criteria (4 listed)
- Age =>18 years at enrollment
- Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
- Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.
- Other inclusion criteria apply.
Key exclusion criteria (4 listed)
- Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
- Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
- AF with a generally reversible cause;
- Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated Other exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Incidence Rate of Stroke or Systemic Embolism - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Incidence Rate of Stroke - Phase II
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Incidence Rate of Stroke - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Incidence Rate of Systemic Embolism (SE) - Phase II
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Incidence Rate of Systemic Embolism (SE) - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Incidence Rate of Pulmonary Embolism (PE) - Phase II
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Incidence Rate of Pulmonary Embolism (PE) - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Incidence Rate of Major Bleeding Events (MBE) - Phase II
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Incidence Rate of Major Bleeding Events (MBE) - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Incidence Rate of Life-threatening Bleeding Events - Phase II
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Incidence Rate of Life-threatening Bleeding Events - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Incidence Rate of Myocardial Infarction (MI) - Phase II
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Incidence Rate of Myocardial Infarction (MI) - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Incidence Rate of All-cause Death - Phase II
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Incidence Rate of All-cause Death - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Incidence Rate of Vascular Death - Phase II
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Incidence Rate of Vascular Death - Phase III
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39511367Joddrell M, El-Bouri W, Harrison SL, Huisman MV, Lip GYH, Zheng Y; GLORIA-AFinvestigators. Machine learning for outcome prediction in patients with non-valvular atrial fibrillation from the GLORIA-AF registry. Sci Rep. 2024 Nov 7;14(1):27088. doi: 10.1038/s41598-024-78120-z.
- Derived from this study: PubMed 38231576Bergler-Klein J, Gotcheva N, Kalejs O, Kalarus Z, Kovacic D, Persic V, Shlyakhto E, Uuetoa T, Huisman MV, Lip GYH, Vinereanu D; GLORIA-AF Investigators. Antithrombotic Usage, Including Three-Year Outcomes With Dabigatran and Vitamin K Antagonists for Atrial Fibrillation, in Eastern Europe: A Descriptive Analysis From Phase 3 of the GLORIA-AF Registry. Am J Ther. 2024 Jan-Feb 01;31(1):e1-e12. doi: 10.1097/MJT.0000000000001655. Epub 2023 Jan 10.
- Derived from this study: PubMed 37753446Romiti GF, Corica B, Proietti M, Mei DA, Frydenlund J, Bisson A, Boriani G, Olshansky B, Chan YH, Huisman MV, Chao TF, Lip GYH; GLORIA-AF Investigators. Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry. EClinicalMedicine. 2023 Aug 25;63:102039. doi: 10.1016/j.eclinm.2023.102039. eCollection 2023 Sep.
- Derived from this study: PubMed 37566295Ding WY, Fawzy AM, Romiti GF, Proietti M, Pastori D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Validating the predictive ability of the 2MACE score for major adverse cardiovascular events in patients with atrial fibrillation: results from phase II/III of the GLORIA-AF registry. J Thromb Thrombolysis. 2024 Jan;57(1):39-49. doi: 10.1007/s11239-023-02866-y. Epub 2023 Aug 11.
- Derived from this study: PubMed 37528405Liu X, Feng G, Marler SV, Huisman MV, Lip GYH, Ma C. Real world time trends in antithrombotic treatment for newly diagnosed atrial fibrillation in China: reports from the GLORIA-AF Phase III registry : Trends in antithrombotic therapy use in China. Thromb J. 2023 Aug 1;21(1):83. doi: 10.1186/s12959-023-00527-x.
- Derived from this study: PubMed 35876418Ding WY, Lane DA, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Incidence and Risk Factors for Residual Adverse Events Despite Anticoagulation in Atrial Fibrillation: Results From Phase II/III of the GLORIA-AF Registry. J Am Heart Assoc. 2022 Aug 2;11(15):e026410. doi: 10.1161/JAHA.122.026410. Epub 2022 Jul 25.
- Derived from this study: PubMed 35488127Ding WY, Calvert P, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Impact of early ablation of atrial fibrillation on long-term outcomes: results from phase II/III of the GLORIA-AF registry. Clin Res Cardiol. 2022 Sep;111(9):1057-1068. doi: 10.1007/s00392-022-02022-1. Epub 2022 Apr 29.
- Derived from this study: PubMed 35294625Lip GYH, Kotalczyk A, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Marler S, Gurusamy VK, Huisman MV; GLORIA-AF Investigators. Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry. Clin Res Cardiol. 2022 May;111(5):560-573. doi: 10.1007/s00392-022-01996-2. Epub 2022 Mar 16.
- Derived from this study: PubMed 35294623Huisman MV, Teutsch C, Lu S, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Lohmann R, Gurusamy VK, Bartels DB, Lip GYH; GLORIA-AF Investigators. Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry. Clin Res Cardiol. 2022 May;111(5):548-559. doi: 10.1007/s00392-021-01957-1. Epub 2022 Mar 16.
- Derived from this study: PubMed 35243870Bayer V, Kotalczyk A, Kea B, Teutsch C, Larsen P, Button D, Huisman MV, Lip GYH, Olshansky B. Global Oral Anticoagulation Use Varies by Region in Patients With Recent Diagnosis of Atrial Fibrillation: The GLORIA-AF Phase III Registry. J Am Heart Assoc. 2022 Mar 15;11(6):e023907. doi: 10.1161/JAHA.121.023907. Epub 2022 Mar 4.
- Derived from this study: PubMed 34895750Lopez-Sendon JL, Alonso-Rodriguez D, Baron-Esquivias G, Cosin-Sales J, Marin F, Galera-Llorca J, Jimenez N, Marler S, Huisman MV, Lip GYH; Spanish GLORIA-AF investigators. Gender differences in antithrombotic treatment in patients with atrial fibrillation from Spain versus the rest of Western Europe. GLORIA-AF Program. Med Clin (Barc). 2022 Aug 26;159(4):177-182. doi: 10.1016/j.medcli.2021.09.016. Epub 2021 Dec 8. English, Spanish.
- Derived from this study: PubMed 33338644Ntaios G, Huisman MV, Diener HC, Halperin JL, Teutsch C, Marler S, Gurusamy VK, Thompson M, Lip GYH, Olshansky B; GLORIA-AF Investigators. Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry. Hellenic J Cardiol. 2021 Mar-Apr;62(2):152-157. doi: 10.1016/j.hjc.2020.11.009. Epub 2020 Dec 15.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
666 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Atrial Fibrillation, run by Boehringer Ingelheim at 666 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 666 sites in United States, China, Japan, Canada, South Korea and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II (time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01468701, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.