AzTrials
AzTrials

Atrial FibrillationPhase 3AVERROESNCT00496769

A Phase III Study of Apixaban in Patients With Atrial Fibrillation

A Phase 3 study testing Apixaban and Acetylsalicylic acid in people with Atrial Fibrillation, run by Bristol-Myers Squibb at 503 sites in 36 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Apixaban and Acetylsalicylic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,421 participants
Where
503 sitesin 36 countries
Study dates
31 Aug 2007to 25 May 2017
Phase
Phase 3
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female
  • Age of 50 years or older
  • Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)
  • At least 1 of the following risk factors for stroke:
  • Prior stroke or transient ischemic attack
  • Age of 75 years or older
Show all 14Show fewer
  • Arterial hypertension on treatment
  • Diabetes mellitus
  • Heart failure (New York Health Authority Class 2 or greater at time of enrollment)
  • Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment
  • Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio <0.9)
  • Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:
  • Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued
  • Vitamin K antagonist therapy not previously used but expected unsuitable

Who cannot join

  • Women who are pregnant or breast feeding
  • Women of child bearing potential who are unwilling to meet the study requirements for pregnancy testing or are unwilling or unable to use an acceptable method to avoid pregnancy
  • Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis
  • Valvular disease requiring surgery
  • Planned ablation procedure for atrial fibrillation to be performed within 3 months
  • Conditions other than atrial fibrillation that require chronic anticoagulation (such as, prosthetic mechanical heart valve, venous thromboembolism)
Show all 20Show fewer
  • Patients with serious bleeding in the last 6 months or at high risk for bleeding, including but not limited to those with:
  • Active peptic ulcer disease
  • Platelet count <100,000/mm^3 or hemoglobin <10g/dL
  • Recent stroke (within 10 days)
  • Documented hemorrhagic tendencies or blood dyscrasias
  • Current alcohol or drug abuse or psychosocial reasons that make study participation impractical
  • Severe comorbid condition with life expectancy <1 year
  • Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a calculated creatinine clearance <25 mL/min is excluded
  • Alanine transaminase or aspartate aminotransferase levels >2 times upper limit of normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative causative factor [such as Gilbert's syndrome] is identified)
  • Allergy or adverse reaction to acetylsalicylic acid
  • Required treatment with a thienopyridine (clopidogrel or ticlopidine)
  • Prisoners or participants who are compulsory detained (involuntarily incarcerated)
  • Use of an investigational drug or device within the past 30 days or prior randomization into an apixaban clinical study
  • Patients who are compulsorily detained for treatment for a psychiatric or physical illness

Trial locations and contacts

503 sites in 36 countries.

503 sites in 36 countries

United States69 sites

  • Capital Cardiology Associates

    Albany, New York, 12211

  • Great Lakes Heart Center Of Alpena

    Alpena, Michigan, 49707

  • Cardiology Consultants Of Orange County Med. Group Inc

    Anaheim, California, 92801

  • Fox Valley Clinical Research Center, Llc

    Aurora, Illinois, 60504

  • Bay Pines Va Healthcare System

    Bay Pines, Florida, 33744

  • Lowcountry Medical Group, Llc

    Beaufort, South Carolina, 29906

  • Ira R. Friedlander, M.D.

    Canton, Ohio, 44710

  • Medical University Of South Carolina

    Charleston, South Carolina, 29425

  • Research Alliance, Inc.

    Clearwater, Florida, 33756

  • The Heart & Vascular Institute Of Florida

    Clearwater, Florida, 33756

  • Missouri Cardiovascular Specialists

    Columbia, Missouri, 65201

  • University Of Missouri

    Columbia, Missouri, 65212

  • Southeast Regional Research Group

    Columbus, Georgia, 31904

  • Davis Heart & Lung Research Institute

    Columbus, Ohio, 43210

  • Nyu Hudson Valley Cardiology

    Cortlandt Manor, New York, 10567

  • Kim A. Klancke, Md

    Daytona Beach, Florida, 32114

  • Henry Ford Hospital K-15

    Detroit, Michigan, 48202

  • Oregon Medical Group - Clinical Research

    Eugene, Oregon, 97401

  • Hunterdon Cardiovascular Associates

    Flemington, New Jersey, 08822

  • The Heart Group Pl

    Fort Myers, Florida, 33908

  • Internal Medicine Of Greer

    Greer, South Carolina, 29650

  • Cardiology Associates Of New Haven,Pc

    Guilford, Connecticut, 06437

  • Pentucket Medical Associates

    Haverhill, Massachusetts, 01830

  • Hillsboro Cardiology Pc

    Hillsboro, Oregon, 97123

  • Hutchinson Clinic, Pa

    Hutchinson, Kansas, 67502

  • Indiana Heart Physicians, Inc.

    Indianapolis, Indiana, 46237

  • The Care Group, Llc

    Indianapolis, Indiana, 46290

  • St. Vincent'S Ambulatory Care, Inc

    Jacksonville, Florida, 32204

  • Baptist Heart Specialists

    Jacksonville Beach, Florida, 32250

  • Glacier View Cardiology, Pc

    Kalispell, Montana, 59901

  • Knoxville Heart Group

    Knoxville, Tennessee, 37916

  • Dr. Jeffrey Chen

    Lafayette, Louisiana, 70506

  • Comprehensive Cardiology Consultants

    Langhorne, Pennsylvania, 19047

  • Terry V. Arnold, Md

    Lexington, North Carolina, 27293

  • Kaiser Permanente Medical Center, West Los Angeles

    Los Angeles, California, 90034

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Michael F. Lesser, Md, Facc Osler Medical Inc.

    Melbourne, Florida, 32901

  • Long Island Heart Associates

    Mineola, New York, 11501

  • Mobile Heart Specialists, Pc

    Mobile, Alabama, 36608

  • Sentara York Clinical Research

    Norfolk, Virginia, 23510

  • North Chicago Va Medical Center

    North Chicago, Illinois, 60064

  • Integris Cardiovascular Physicians

    Oklahoma City, Oklahoma, 73112

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma, 73135

  • Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group

    Palm Springs, California, 92262

  • Michigan Heart And Vascular Specialists

    Petoskey, Michigan, 49770

  • Pinehurst Medical Clinic, Inc

    Pinehurst, North Carolina, 28374

  • Yogesh K. Paliwal Md

    Pomona, California, 91767

  • The Portland Clinic, Llp

    Portland, Oregon, 97205

  • San Diego Managed Care Group

    Poway, California, 92064

  • Roanoke Heart Institute, Plc

    Roanoke, Virginia, 24014

  • Academic Cardiology Associates

    Rochester Hills, Michigan, 48307

  • Salem Veterans Administration Medical Center

    Salem, Virginia, 24153

  • Peninsula Cardiology Associates, P.A.

    Salisbury, Maryland, 21804

  • University Of California, San Diego

    San Diego, California, 92103

  • Sanford Cardiology

    Sanford, North Carolina, 27330

  • Santa Rosa Cardiology

    Santa Rosa, California, 95405

  • Cardiovascular Center Of Sarasota

    Sarasota, Florida, 34239

  • Dr William Kufs

    Saratoga Springs, New York, 12866

  • Southeast Regional Research Group

    Savannah, Georgia, 31406

  • Grand View - Lehigh Valley Health Services

    Sellersville, Pennsylvania, 18960

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • The Broward Heart Group, Pa

    Tamarac, Florida, 33321

  • Capital Cardiology Associates

    Troy, New York, 12180

  • Southwest Heart

    Tucson, Arizona, 85710

  • Tupelo Neurology Clinic, Pa

    Tupelo, Mississippi, 38801

  • North County Internal Medicine

    Vista, California, 92083

  • Walla Walla Clinic

    Walla Walla, Washington, 99362

  • West Chester Cardiology

    West Chester, Pennsylvania, 19380

  • Cardiology Consultants Of Philadelphia

    Yardley, Pennsylvania, 19067

Other trials in United States

Russia43 sites

  • Local Institution

    Barnaul, 656055

  • Local Institution

    Chelyabinsk, 454136

  • Local Institution

    Kaluga, Anenki, 248007

  • Local Institution

    Kazan', 420012

  • Local Institution

    Kemerovo, 650002

  • Local Institution

    Krasnodar, 350042

  • Local Institution

    Moscow, 101990

  • Local Institution

    Moscow, 105066

  • Local Institution

    Moscow, 109240

  • Local Institution

    Moscow, 111539

  • Local Institution

    Moscow, 117485

  • Local Institution

    Moscow, 119121

  • Local Institution

    Moscow, 121356

  • Local Institution

    Moscow, 121552

  • Local Institution

    Moscow, 125284

  • Local Institution

    Moscow, 125367

  • Local Institution

    Moscow, 127644

  • Local Institution

    Moscow, 129301

  • Local Institution

    Moscow, 129336

  • Local Institution

    Moscow, 143000

  • Local Institution

    Nizhny Novgorod, 603035

  • Local Institution

    Novosibirsk, 630047

  • Local Institution

    Perm, 614097

  • Local Institution

    Perm, 614107

  • Local Institution

    Ryazan, 390026

  • Local Institution

    Saint Petersburg, 190000

  • Local Institution

    Saint Petersburg, 191025

  • Local Institution

    Saint Petersburg, 193079

  • Local Institution

    Saint Petersburg, 193144

  • Local Institution

    Saint Petersburg, 194156

  • Local Institution

    Saint Petersburg, 194291

  • Local Institution

    Saint Petersburg, 195112

  • Local Institution

    Saint Petersburg, 197198

  • Local Institution

    Samara, 443070

  • Local Institution

    Samara, 443095

  • Local Institution

    Saratov, 410028

  • Local Institution

    Saratov, 410054

  • Local Institution

    Tomsk, 634012

  • Local Institution

    Tver', 170036

  • Local Institution

    Tyumen, 625023

  • Local Institution

    Yaroslavl, 150062

  • Local Institution

    Yekaterinburg, 620109

  • Local Institution

    Yekaterinburg, 620144

Other trials in Russia

Brazil32 sites

  • Local Institution

    Belém, Pará, 66087

  • Local Institution

    Belo Horizonte, Minas Gerais, 30150

  • Local Institution

    Blumenau, Santa Catarina, 89010

  • Local Institution

    Botucatu, São Paulo, 18600

  • Local Institution

    Campina Grande do Sul, Paraná, 83430

  • Local Institution

    Campinas, São Paulo, 13059

  • Local Institution

    Curitiba, Paraná, 80010

  • Local Institution

    Curitiba, Paraná, 80730

  • Local Institution

    Marília, São Paulo, 17515

  • Local Institution

    Marília, São Paulo, 17519

  • Local Institution

    Maringá, Paraná, 87015

  • Local Institution

    Natal, Rio Grande do Norte, 59020

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90020

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90110

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90610

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90620

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 91350

  • Local Institution

    Rio de Janeiro, 20551

  • Local Institution

    Salvador, Estado de Bahia, 40144

  • Local Institution

    Salvador, Estado de Bahia, 41810

  • Local Institution

    San Jose- Do Rio Preto, São Paulo, 15015

  • Local Institution

    São José, Santa Catarina, 88103

  • Local Institution

    São José do Rio Preto, São Paulo, 15015

  • Local Institution

    São José do Rio Preto, São Paulo, 15025

  • Local Institution

    São José do Rio Preto, São Paulo, 15090

  • Local Institution

    São Paulo, 040112-180

  • Local Institution

    São Paulo, 04012

  • Local Institution

    São Paulo, 04038

  • Local Institution

    São Paulo, 05403

  • Local Institution

    Uberaba, Minas Gerais, 38010

  • Local Institution

    Uberaba, Minas Gerais, 38025

Other trials in Brazil

Canada29 sites

  • Local Institution

    Brampton, Ontario, L6W 2X7

  • Local Institution

    Burlington, Ontario, L7M 4Y1

  • Local Institution

    Cambridge, Ontario, N1R 6V6

  • Local Institution

    Cambridge, Ontario, N1R 7R1

  • Local Institution

    Greater Sudbury, Ontario, P3C 5K7

  • Local Institution

    Greater Sudbury, Ontario, P3E 2N8

  • Local Institution

    Greenfield Park, Quebec, J4V 2G8

  • Local Institution

    Grimsby, Ontario, L3M 1P3

  • Local Institution

    Hamilton, Ontario, L8L 2X2

  • Local Institution

    Hamilton, Ontario, L8M 1K7

  • Local Institution

    Montreal, Quebec, H1T 1C8

  • Local Institution

    Montreal, Quebec, H2K 4L5

  • Local Institution

    Montreal, Quebec, H2W 1T8

  • Local Institution

    New Westminster, British Columbia, V3L 3W4

  • Local Institution

    Oshawa, Ontario, L1H 1B9

  • Local Institution

    Oshawa, Ontario, L1J 2J9

  • Local Institution

    Ottawa, Ontario, K1Y 4W7

  • Local Institution

    Québec, Quebec, G1J 1Z6

  • Local Institution

    Saint Georges Beauce, Quebec, G5Y 4W1

  • Local Institution

    Saint-Jérôme, Quebec, J7Z 5T3

  • Local Institution

    Saint-Lambert, Quebec, J4P 2H4

  • Local Institution

    Sarnia, Ontario, N7T 4X3

  • Local Institution

    Saskatoon, Saskatchewan, S7L OY7

  • Local Institution

    Terrebonne, Quebec, J6V 2H2

  • Local Institution

    Toronto, Ontario, M4N 3M5

  • Local Institution

    Toronto, Ontario, M5B 1W8

  • Local Institution

    Westmount, Quebec, H3Z 2M6

  • Local Institution

    Weston, Ontario, M9N 1W4

  • Local Institution

    Winnipeg, Manitoba, R2V 4W3

Other trials in Canada

Argentina28 sites

  • Local Institution

    Adrogué, Buenos Aires, 1846

  • Local Institution

    Autonoma Buenos Aires, Buenos Aires, C1119ACN

  • Local Institution

    Bahía Blanca, Buenos Aires, B8000FTD

  • Local Institution

    Buenos Aires, 1221

  • Local Institution

    Córdoba, 5000

  • Local Institution

    Córdoba, 5016

  • Local Institution

    Córdoba, X5000AAX

  • Local Institution

    Córdoba, X5000EPU

  • Local Institution

    Córdoba, X5000EVQ

  • Local Institution

    Córdoba, X5009BSN

  • Local Institution

    Coronel Suárez, Buenos Aires, B7540GHD

  • Local Institution

    Corrientes, 3400

  • Local Institution

    Haedo, Buenos Aires, B1706AJU

  • Local Institution

    La Plata, Buenos Aires, B1900AXI

  • Local Institution

    La Plata, Buenos Aires, B1902COS

  • Local Institution

    Mar del Plata, Buenos Aires, B7600FZN

  • Local Institution

    Merlo, Buenos Aires, B1722COV

  • Local Institution

    Ramos Mejía, Buenos Aires, B1704ETD

  • Local Institution

    Rosario, Santa Fe Province, 2000

  • Local Institution

    Rosario, Santa Fe Province, S2000CVB

  • Local Institution

    Rosario, Santa Fe Province, S2001ODA

  • Local Institution

    Salta, A4406CLA

  • Local Institution

    San Francisco, Córdoba Province, X2400MHC

  • Local Institution

    San Miguel de Tucumán, Tucumán Province, T4000ICL

  • Local Institution

    San Miguel de Tucumán, Tucumán Province, T4000JCU

  • Local Institution

    San Salvador de Jujuy, Jujuy Province, Y4600ABF

  • Local Institution

    Santa Fe, 3000

  • Local Institution

    Zárate, Provincia Buenos Aires, B2800DGH

Other trials in Argentina

Germany24 sites

  • Local Institution

    Berlin, 10117

  • Local Institution

    Berlin, 12099

  • Local Institution

    Berlin, 13353

  • Local Institution

    Bonn, 53115

  • Local Institution

    Cologne, 51067

  • Local Institution

    Essen, 45147

  • Local Institution

    Frankfurt am Main, 60590

  • Local Institution

    Halle, 06097

  • Local Institution

    Hamburg, 22291

  • Local Institution

    Hamburg, 22299

  • Local Institution

    Hamburg, 22527

  • Local Institution

    Heidelberg, 69115

  • Local Institution

    Heidelberg, 69120

  • Local Institution

    Kassel, 34121

  • Local Institution

    Leipzig, 04104

  • Local Institution

    Magdeburg, 39112

  • Local Institution

    Mainz, 55116

  • Local Institution

    Mainz, 55131

  • Local Institution

    Mannheim, 68167

  • Local Institution

    Papenburg, 26871

  • Local Institution

    Regensburg, 93053

  • Local Institution

    Riesa, 01587

  • Local Institution

    Witten, 58455

  • Local Institution

    Wolmirstedt, 39326

Other trials in Germany

Poland24 sites

  • Local Institution

    Częstochowa, 42-200

  • Local Institution

    Elblag, 82-300

  • Local Institution

    Gdynia, 81-423

  • Local Institution

    Gliwice, 44-100

  • Local Institution

    Gniewkowo, 88-140

  • Local Institution

    Grodzisk Mazowiecki, 05-825

  • Local Institution

    Inowrocław, 88-100

  • Local Institution

    Kielce, 25-736

  • Local Institution

    Krakow, 30-092

  • Local Institution

    Krakow, 31-501

  • Local Institution

    Lodz, 91-302

  • Local Institution

    Piotrkow Trybunalski, 97-300

  • Local Institution

    Płock, 09-402

  • Local Institution

    Poznan, 60-539

  • Local Institution

    Puławy, 24-100

  • Local Institution

    Siemianowice Śląskie, 41-100

  • Local Institution

    Skierniewice, 96-100

  • Local Institution

    Tarnów, 33-100

  • Local Institution

    Warsaw, 00-217

  • Local Institution

    Warsaw, 03-242

  • Local Institution

    Warsaw, 04-073

  • Local Institution

    Węgrów, 07-100

  • Local Institution

    Zabrze, 41-800

  • Local Institution

    Żarów, 58-130

Other trials in Poland

India19 sites

  • Local Institution

    Ahmedabad, 380060

  • Local Institution

    Bangalore, Karnataka, 560052

  • Local Institution

    Bangalore, 560034

  • Local Institution

    Banglore, Karnataka, 560054

  • Local Institution

    Bikaner, 334 003

  • Local Institution

    Chennai, Tamil Nadu, 600081

  • Local Institution

    Dhantoli, Nagpur, 440012

  • Local Institution

    Hyderabad, Andhra Pradesh, 500001

  • Local Institution

    Indore, 452001

  • Local Institution

    Jaipur, 302001

  • Local Institution

    Kottayam, 686016

  • Local Institution

    Lucknow, Uttar Pradesh, 226003

  • Local Institution

    Mumbai, Maharashtra, 400007

  • Local Institution

    Mumbai, Maharashtra, 400052

  • Local Institution

    Mysore, Karnataka, 570020

  • Local Institution

    Nagpur, Maharashtra, 440012

  • Local Institution

    Nashik, Maharashtra, 422002

  • Local Institution

    Pune, Maharashtra, 411001

  • Local Institution

    Pune, 411030

Other trials in India

Mexico18 sites

  • Local Institution

    Acapulco de Juárez, Guerrero, 39570

  • Local Institution

    Aguascalientes, 20127

  • Local Institution

    Aguascalientes, 20230

  • Local Institution

    Chihuahua City, 31203

  • Local Institution

    Ciudad López Mateos, State of Mexico, 52975

  • Local Institution

    Culiacán, Sinaloa, 80020

  • Local Institution

    Durango, 34080

  • Local Institution

    Guadalajara, Jalisco, 44600

  • Local Institution

    Guadalajara, Jalisco, 44670

  • Local Institution

    Hermosillo, Sonora, 83190

  • Local Institution

    Jalapa, Veracruz, 91020

  • Local Institution

    Mexico City, Mexico City, 06726

  • Local Institution

    Mexico City, Mexico City, 14080

  • Local Institution

    Monterrey, Nuevo León, 64240

  • Local Institution

    Querétaro, 76000

  • Local Institution

    San Luis Potosí City, 78200

  • Local Institution

    San Luis Potosi, Slp, San Luis Potosí, 78240

  • Local Institution

    Zapopan, Jalisco, 45200

Other trials in Mexico

United Kingdom18 sites

  • Local Institution

    Aberdeen, Aberdeenshire, AB25 2ZN

  • Local Institution

    Barnsley, South Yorkshire, S75 2EP

  • Local Institution

    Basildon, Essex, SS16 5NL

  • Local Institution

    Birmingham, West Midlands, B18 7QH

  • Local Institution

    Blackpool, Lancashire, FY3 8NR

  • Local Institution

    Chesterfield, Derbyshire, S44 5BL

  • Local Institution

    Chichester, West Sussex, PO19 6SE

  • Local Institution

    Craigavon, Portadown, BT63 5QQ

  • Local Institution

    Glasgow, Lanarkshire, G11 6NT

  • Local Institution

    Glasgow, Lanarkshire, G51 4TF

  • Local Institution

    Kirkcaldy, Fife, KY2 5AH

  • Local Institution

    Larbert, Stirlingshire, FK5 4WR

  • Local Institution

    London, Greater London, SW17 ORE

  • Local Institution

    Newcastle Upon, Tyne and Wear, NE2 4HH

  • Local Institution

    Northampton, Northamptonshire, NN1 5BD

  • Local Institution

    Paisley, Renfrewshire, PA2 9PN

  • Local Institution

    Romford, Essex, RM7 0AG

  • Local Institution

    Worksop, Nottinghamshire, S18 0BD

Other trials in United Kingdom

China16 sites

  • Local Institution

    Beijing, Beijing Municipality, 100020

  • Local Institution

    Beijing, Beijing Municipality, 100029

  • Local Institution

    Beijing, Beijing Municipality, 100037

  • Local Institution

    Beijing, Beijing Municipality, 100038

  • Local Institution

    Beijing, Beijing Municipality, 100088

  • Local Institution

    Beijing, Beijing Municipality, 100853

  • Local Institution

    Chengdu, Sichuan, 610041

  • Local Institution

    Dalian, Liaoning, 116033

  • Local Institution

    Guangzhou, Guangdong, 510180

  • Local Institution

    Qingdao, Shandong, 266071

  • Local Institution

    Shanghai, Shanghai Municipality, 200025

  • Local Institution

    Shanghai, Shanghai Municipality, 200433

  • Local Institution

    Shenyang, Liaoning, 110001

  • Local Institution

    Shijiazhuang, Hebei, 050082

  • Local Institution

    Suzhou, Jiangsu, 215006

  • Local Institution

    Wuhan, Hubei, 430060

Other trials in China

Czechia15 sites

  • Local Institution

    Brno, 656 91

  • Local Institution

    Havirov - Mesto, 736 01

  • Local Institution

    Jindřichův Hradec, 377 38

  • Local Institution

    Kladno, 272 59

  • Local Institution

    Kroměříž, 767 55

  • Local Institution

    Městec Králové, 289 03

  • Local Institution

    Ostrava, 702 00

  • Local Institution

    Písek, 397 01

  • Local Institution

    Prague, 110 00

  • Local Institution

    Prague, 128 08

  • Local Institution

    Prague, 150 00

  • Local Institution

    Přelouč, 535 01

  • Local Institution

    Příbram, 261 26

  • Local Institution

    Slaný, 274 01

  • Local Institution

    Ústí nad Orlicí, 562 18

Other trials in Czechia

Ukraine13 sites

  • Local Institution

    Dnipropetrovsk, 49005

  • Local Institution

    Donetsk, 83114

  • Local Institution

    Kharkiv, 61002

  • Local Institution

    Kharkiv, 61018

  • Local Institution

    Kharkiv, 61029

  • Local Institution

    Kharkiv, 61115

  • Local Institution

    Kharkiv, 61176

  • Local Institution

    Kyiv, 01023

  • Local Institution

    Kyiv, 02091

  • Local Institution

    Kyiv, 02660

  • Local Institution

    Kyiv, 03680

  • Local Institution

    Kyiv, 04107

  • Local Institution

    Kyiv, 04114

Other trials in Ukraine

Israel12 sites

  • Local Institution

    Afula, 18101

  • Local Institution

    Ashkelon, 78278

  • Local Institution

    Giv‘atayim, 53583

  • Local Institution

    Hadera, 38100

  • Local Institution

    Haifa, 31096

  • Local Institution

    Haifa, 34362

  • Local Institution

    Holon, 58100

  • Local Institution

    Nazareth, 16000

  • Local Institution

    Nazareth, 16100

  • Local Institution

    Petah Tikva, 49100

  • Local Institution

    Safed, 13100

  • Local Institution

    Tel Aviv, 64239

Other trials in Israel

Australia10 sites

  • Local Institution

    Auchenflower, Queensland, 4066

  • Local Institution

    Coffs Harbour, New South Wales, 2450

  • Local Institution

    Concord, New South Wales, 2139

  • Local Institution

    Geelong, Victoria, 3220

  • Local Institution

    Gosford, New South Wales, 2250

  • Local Institution

    Joondalup, Western Australia, 6027

  • Local Institution

    Kingswood, New South Wales, 2747

  • Local Institution

    Kippa-Ring, Queensland, 4021

  • Local Institution

    Milton, Queensland, 4064

  • Local Institution

    Woolloongabba, Queensland, 4102

Other trials in Australia

Chile10 sites

  • Local Institution

    Osorno, Los Lagos Region

  • Local Institution

    Santiago, Santiago Metropolitan, 7500520

  • Local Institution

    Santiago, Santiago Metropolitan, 7600448

  • Local Institution

    Santiago, Santiago Metropolitan, 8330074

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    Santiago, Santiago Metropolitan, 8360160

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    Santiago, Santiago Metropolitan, 8900085

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    Temuco, Araucania, 4781173

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    Valdivia, Los Ríos Region, 5111847

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    Victoria, Araucania, 4720000

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    Viña del Mar, Valparaiso, 2570017

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Indonesia10 sites

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    Bandung, 40161

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    Denpasar, 80114

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    Jakarta, 10430

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    Jakarta, 13310

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    Malang, East Java, 65111

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    Padang, 25137

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    Palembang, 30126

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    Surabaya, 60286

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    Yogyakarta, 55284

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South Korea10 sites

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    Busan, 602-702

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    Daegu, 700-721

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    Daejeon, 302-718

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    Goyang-si, Gyeonggi-do, 411-773

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    Guri-si, Gyeonggi-do, 471-701

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    Gwangju, 501-757

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    Seongnam-si, Gyeonggi-do, 463-707

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    Seoul, 110-744

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    Seoul, 130-709

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    Seoul, 143-729

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Belgium9 sites

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    Aalst, 9300

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    Brasschaat, 2930

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    Brussels, 1070

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    Brussels, 1090

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    De Pinte, 9840

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    Genk, 3600

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    Huy, 4500

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    Roeselare, 8800

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    Turnhout, 2300

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Italy9 sites

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    Ascoli Piceno, 63100

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    Chieti, 66013

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    Genova, 16132

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    Isernia, 86170

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    Lido di Camaiore, 55043

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    Palermo, 90127

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    Perugia, 06126

  • Local Institution

    San Daniele de Friuli (ud), 33038

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    Sassari, 07100

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France8 sites

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    Abbeville, 80142

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    Albi, 81013

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    Cholet, 49325

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    Grenoble, 38043

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    Langres, 52206

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    Paris, 75018

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    Sisteron, 04203

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    Toulon, 83041

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Philippines8 sites

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    Biñan, Laguna, 4024

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    Cagayan de Oro, 9000

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    Cavite, 4114

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    City of Muntinlupa, 1780

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    Iligan City, Lanao DEL Norte, 9200

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    Laoag, 2900

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    Manila, 1000

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    Naga, Camarines SUR, 4400

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South Africa8 sites

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    Alberton, Gauteng, 1450

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    Bellville, Cape Town, Western Cape, 7530

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    Bloemfontein, Free State, 9300

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    Bloemfontein, Free State, 9301

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    Cape Town, Western Cape, 7925

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    Pretoria, 0041

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    Somerset West, Western Cape, 7130

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    Worcester, Western Cape, 6850

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Spain7 sites

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    Albacete, 02006

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    L'Hospitalet de Llobregat, Barcelona, 08907

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    Lugo, Galicia, 27003

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    Madrid, 28007

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    Madrid, 28034

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    Torrevieja, Alicante, 03186

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    Valencia, 46017

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Sweden7 sites

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    Gothenburg, 416 85

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    Mölndal, 431 80

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    Uppsala, 751 85

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Malaysia6 sites

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    Johor Bahru, Johor, 80100

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    Kuala Lumpur, 50586

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    Kuala Lumpur, 59100

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Taiwan6 sites

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    Taipei, 111

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    Taipei, 220

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Colombia5 sites

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    Barranquilla, Atlántico

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    Bogotá

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    Bucaramanga, Santander Department

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    Cali, Valle del Cauca Department

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    Medellín, Antioquia

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Finland5 sites

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    Espoo, 02740

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    Helsinki, 00029 HUS

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    Jyväskylä, 40100

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    Kuopio, FI-70100

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    Tampere, 33900

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Austria4 sites

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    Graz, 8036

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    Linz, 4020

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Norway4 sites

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    Fyllingsdal, 5145

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Singapore4 sites

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    Singapore, 169609

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    Singapore, 308433

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    Singapore, 768828

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Turkey (Türkiye)4 sites

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    Isparta, 32100

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    Istanbul, 34304

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    Istanbul, 34390

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    Kirikkale, 71100

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Denmark3 sites

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    Arhus C, 8000

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    Esbjerg, 6700

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    Frederiksberg, 2000

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Greece3 sites

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    Thebes, 32200

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Hong Kong3 sites

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    Chai Wan

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    Shatin, NEW Territories

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About this study

Official title: Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial

The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.

Read the detailed description

An optional Long-term Open-label Extension Phase of treatment with apixaban will be provided for qualifying participants following the conclusion of the double-blind phase

Being tested
Apixaban, Acetylsalicylic acid
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApixabanDrug

    Also called BMS-562247

    Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks

  • Acetylsalicylic acidDrug

    Tablets, oral, 81-324 mg, once daily, up to 156 weeks

Study groups in NCT00496769
Study groupRoleWhat they receive
ApixabanExperimentalNot described
Receives: Drug: Apixaban
Acetylasalicylic acidActive comparatorNot described
Receives: Drug: Acetylsalicylic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period

    Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)

    Measured: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

Secondary outcomes (8)

  1. Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period

    Event rate=percent of participants with an event divided by the total participants in the arm.

    Measured: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

  2. Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death

    Event rate=percent of participants with an event divided by the total participants in the arm.

    Measured: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

  3. Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period

    Event rate=percent of participants with an event divided by the total participants in the arm.

    Measured: First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010

  4. Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period

    Event rate=percent of participants with an event divided by the total participants in the arm.

    Measured: Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

  5. Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome

    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

    Measured: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

  6. Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality

    BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value ≤8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/μL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/μL), low if <0.8*BL and BL<LLN or <LLN and BL >ULN or <0.75*LLN when BL is missing or LLN ≤BL≤ ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL<LLN or >1.25*ULN when BL is missing or LLN≤BL≤ULN; neutrophils (absolute), low: <1.0*10^3 cells/μL; eosinophils (absolute), high: >0.750*10^3 cells/μL; basophils (absolute), high: >0.4*10^3 cells/μL; monocytes (absolute), high: 2*10^3 cells/μL; lymphocytes (absolute), low if <0.75*10^3 cells/μL, high if >7.50*10^3 cells/μL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN.

    Measured: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

  7. Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)

    LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BL<LLN or <LLN and BL>ULN or <0.95*LLN when BL missing or LLN ≤BL≤ULN, high if >1.05*BL and BL>ULN or >ULN and BL<LLN or >1.05*ULN when BL missing or LLN≤BL≤ULN; potassium(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL and BL>ULN or>ULN and BL<LLN or >1.10*ULN when BL missing or LLN≤BL≤ULN; chloride(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL ≤ULN, high if >1.10*BL and BL>ULN or >ULN and BL<LLN or >1.10* ULN if BL missing or LLN≤BL≤ULN; calcium(mg/dL):low if <0.75*BL and BL<LLN or <LLN and BL>ULN or <0.80*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL and BL>ULN or >ULN if BL<LLN or >1.20*ULN if BL missing or LLN≤BL≤ULN ; bicarbonate(mEq/L):low if <0.75*BL when BL<LLN or <LLN when BL>ULN or <0.75*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL when BL>ULN or >ULN

    Measured: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

  8. Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)

    ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BL<LLN or <LLN when B >ULN or <0.90*LLN when BL is missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN when BL<LLN or >1.10*ULN if BL missing or LLN≤BL≤ULN.Protein,total(g/L): low if <0.90*BL if BL<LLN or <LLN if BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN if BL<LLN or >1.10*ULN if BL or LLN≤BL≤ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BL<LLN or <LLN when BL>ULN or <0.8*LLN when BL missing or LLN≤BL≤ULN, high if >2*BL when BL>ULN or >ULN when BL<LLN or >1.5*ULN if BL missing or LLN≤BL≤ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL≤ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: ≥2 if BL=missing,=0 or =0.5 or if ≥3 if BL=1, or if ≥4 and BL≥2.

    Measured: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2007 (estimated)
  2. Study start31 Aug 2007
  3. Primary completion30 Nov 2010
  4. Study completion25 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
6,421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00496769
Sponsor's protocol ID
CV185-048
Acronym
AVERROES
Status last verified
May 2018
First submitted
2 Jul 2007
Last updated
15 Jun 2018
Data monitoring committee
Yes

Publications

  • Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.

    PubMed 35570249

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

    PubMed 35224730

  • Bhagirath VC, Eikelboom JW, Hirsh J, Coppens M, Ginsberg J, Vanassche T, Yuan F, Chan N, Yusuf S, Connolly SJ. Apixaban-Calibrated Anti-FXa Activity in Relation to Outcome Events and Clinical Characteristics in Patients with Atrial Fibrillation: Results from the AVERROES Trial. TH Open. 2017 Dec 12;1(2):e139-e145. doi: 10.1055/s-0037-1613679. eCollection 2017 Jul.

    PubMed 31249919

  • Ng KH, Shestakovska O, Connolly SJ, Eikelboom JW, Avezum A, Diaz R, Lanas F, Yusuf S, Hart RG. Efficacy and safety of apixaban compared with aspirin in the elderly: a subgroup analysis from the AVERROES trial. Age Ageing. 2016 Jan;45(1):77-83. doi: 10.1093/ageing/afv156. Epub 2015 Nov 19.

    PubMed 26590293

  • Hohnloser SH, Shestakovska O, Eikelboom J, Franzosi MG, Tan RS, Zhu J, Yusuf S, Connolly SJ. The effects of apixaban on hospitalizations in patients with different types of atrial fibrillation: insights from the AVERROES trial. Eur Heart J. 2013 Sep;34(35):2752-9. doi: 10.1093/eurheartj/eht292. Epub 2013 Jul 25.

    PubMed 23892201

  • Lip GY, Connolly S, Yusuf S, Shestakovska O, Flaker G, Hart R, Lanas F, Xavier D, Eikelboom J; ERROES Investigators. Modification of outcomes with aspirin or apixaban in relation to CHADS(2) and CHA(2)DS(2)-VASc scores in patients with atrial fibrillation: a secondary analysis of the AVERROES study. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):31-8. doi: 10.1161/CIRCEP.112.975847. Epub 2013 Feb 6.

    PubMed 23390125

  • Flaker GC, Eikelboom JW, Shestakovska O, Connolly SJ, Kaatz S, Budaj A, Husted S, Yusuf S, Lip GY, Hart RG. Bleeding during treatment with aspirin versus apixaban in patients with atrial fibrillation unsuitable for warfarin: the apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment (AVERROES) trial. Stroke. 2012 Dec;43(12):3291-7. doi: 10.1161/STROKEAHA.112.664144. Epub 2012 Oct 2.

    PubMed 23033347

  • Diener HC, Eikelboom J, Connolly SJ, Joyner CD, Hart RG, Lip GY, O'Donnell M, Hohnloser SH, Hankey GJ, Shestakovska O, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban versus aspirin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a predefined subgroup analysis from AVERROES, a randomised trial. Lancet Neurol. 2012 Mar;11(3):225-31. doi: 10.1016/S1474-4422(12)70017-0. Epub 2012 Feb 1.

    PubMed 22305462

  • Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O'Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 Mar 3;364(9):806-17. doi: 10.1056/NEJMoa1007432. Epub 2011 Feb 10.

    PubMed 21309657

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apixaban and Acetylsalicylic acid in people with Atrial Fibrillation, run by Bristol-Myers Squibb at 503 sites in 36 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 14 inclusion and 20 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 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 503 sites in United States, Russia, Brazil, Canada, Argentina and 31 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2013). 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?

Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period (time frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)). 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 NCT00496769, which also lists 9 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 15 Jun 2018.

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