Cardio-pulmonary BypassPhase 3NCT00048308
Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass
A Phase 3 study testing pexelizumab in people with Cardio-pulmonary Bypass and Coronary Artery Bypass Graft, run by Alexion Pharmaceuticals, Inc. at 186 sites in 2 countries.
Trial summary
During a heart bypass procedure, a substance called "complement" is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, heart failure, or impairment of memory, language and motor skills. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardio-pulmonary Bypass, Coronary Artery Bypass Graft
- What is being tested?
- pexelizumab
- How many people
- 3,000 participants
- Where
- 186 sitesin 2 countries
- Study dates
- Jan 2002to Mar 2003
- Phase
- Phase 3
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
Who may be able to join
- The study population will be drawn from patients undergoing CABG or CABG plus valve surgery using a bypass pump. In addition, they must meet all of the following criteria:
- be at least 18 years of age;
- have one or more of the following risk factors:
- diabetes mellitus;
- prior CABG;
- the need for urgent intervention, defined according to the American College of Cardiology/ American Heart Association (ACC/AHA) guidelines as being patients who are required to stay in the hospital, but may be scheduled and operated on within a normal scheduling routine, excluding patients who have had a MI within 48 hours of CABG;
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- female;
- history of a neurologic event (cerebrovascular accident, transient ischemic attack or carotid endarterectomy);
- history of congestive heart failure (New York Heart Association [NYHA]Class III or IV);
- history of 2 myocardial infarctions, or a myocardial infarction that occurred greater than 48 hours but less than four (4) weeks prior to CABG;
- provide Informed Consent.
Who cannot join
- A patient will be ineligible for study entry if he/she meets any of the following exclusion criteria:
- has planned aortic dissection repair and/or requires aortic root reconstruction;
- requires salvage intervention as defined by the ACC/AHA guidelines as being ongoing cardiopulmonary resuscitation on the way to the operating room;
- has current cardiogenic shock, acute left ventricular rupture, acute septal rupture or acute papillary muscle rupture;
- has uncontrolled diabetes, defined as a documented plasma blood glucose value > 400 mg/dl (22.2 mmol/L) within three (3) days before surgery;
- has a history of renal failure and a serum creatinine value greater than 3.0 mg/dl;
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- has a history of chronic hepatic failure and/or hepatic cirrhosis;
- has a history of malignancy, excepting basal cell carcinoma and malignancies in remission (greater than 2 years);
- has any active bacterial or other infection which is clinically significant, in the opinion of the investigator (e.g. evaluate the evidence based on WBC, temperature, cultures, etc. as appropriate for the patient);
- has any serious medical condition which, in the opinion of the investigator is likely to alter the patient's course of recovery or the evaluation of the study medication's safety;
- has a history of alcohol or drug abuse within the past year;
- has a known or suspected hereditary complement deficiency;
- has participated in any other investigational drug study or was exposed to an investigational agent or device within 30 days of randomization;
- is receiving, or is planning to receive, any other investigational drug or device, or will participate in any other research study during the trial;
- is pregnant or breast-feeding.
Trial locations and contacts
186 sites in 2 countries.
186 sites in 2 countries
United States168 sites
Akron General Medical Center
Akron, Ohio, 44307
Summa Health Systems
Akron, Ohio, 44309
Appleton Medical Center
Appleton, Wisconsin, 54911
Cardiovascular and Thoracic Surgery Associates
Arlington, Virginia, 22205
Asheville Cardiothoracic Surgeons
Asheville, North Carolina, 28803
Emory University Hospital
Atlanta, Georgia, 30322
St. Joseph's Hospital
Atlanta, Georgia, 30342
Florida Cardiovascular Research
Atlantis, Florida, 33462
University Hospital
Augusta, Georgia, 30901
Brackenridge Hospital
Austin, Texas, 78701
Seton Medical Center
Austin, Texas, 78705
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Union Memorial Hospital
Baltimore, Maryland, 21218
Bend Memorial Clinic
Bend, Oregon, 97701
Brotman Medical Center
Beverly Hills, California, 90210
Baptist Medical Center Cardiology
Birmingham, Alabama, 35211
University of Alabama at Birmingham
Birmingham, Alabama, 35249-6880
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Womens Hospital
Boston, Massachusetts, 02115
St. Vincent's Medical Center
Bridgeport, Connecticut, 06606
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Maimonides Medical Center
Brooklyn, New York, 11219
Cardiovascular Associates of the Peninsula
Burlingame, California, 94401
Fletcher Allen Health Care
Burlington, Vermont, 05401
Camcare Health Education & Research Institute
Charleston, West Virginia, 25304
The Chattanooga Heart Institute Cardiovascular Group, P.C.
Chattanooga, Tennessee, 37404
Northwestern Univ. Medical Center
Chicago, Illinois, 60611
Northwestern University Medical Center
Chicago, Illinois, 60611
University of Illinois - Chicago
Chicago, Illinois, 60612
Good Samaritan Hospital
Cincinnati, Ohio, 45219
Sterling Research Group
Cincinnati, Ohio, 45219
Good Samaritan Hospital -Seton Center
Cincinnati, Ohio, 45220
Tri Health Bethesda North Hospital
Cincinnati, Ohio, 45242
Cardiology diagnostics, Ltd.
City of Saint Peters, Missouri, 63376
Morton Plan Mease Health Care
Clearwater, Florida, 33756
University Hopital of Cleveland
Cleveland, Ohio, 44106
Mt. Carmel West
Columbus, Ohio, 43222
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Seton Medical Center
Daly City, California, 94015
Dayton Heart Center
Dayton, Ohio, 45414
VA Medical Center- Atlanta
Decatur, Georgia, 30033
South Denver Cardiology Associates
Denver, Colorado, 80111
Western Cardiology Associates
Denver, Colorado, 80218
Iowa Heart Center - Laurel
Des Moines, Iowa, 50314
Henry Ford Hospital
Detroit, Michigan, 48202
The Heart Center
Doylestown, Pennsylvania, 18901
St. Luke's Hospital-Duluth
Duluth, Minnesota, 55805
St. Mary's Duluth Health System
Duluth, Minnesota, 55805
Duke University Medical Center
Durham, North Carolina, 27710
Evanston Northwestern Healthcare Evanston Hospital
Evanston, Illinois, 60201
Inova Fairfax Hospital
Falls Church, Virginia, 22043
McLaren Regional Medical Center
Flint, Michigan, 48532
Heart and Vascular Clinic of Northern CO
Fort Collins, Colorado, 80528
Heart Group Research
Fort Lauderdale, Florida, 33308
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901
Indiana Ohio Heart
Fort Wayne, Indiana, 46804
Mary Washington Hospital
Fredericksburg, Virginia
St. Jude Medical Center
Fullerton, California, 92835
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035
Straub Clinic and Hospital
Honolulu, Hawaii, 96813-3009
Kaiser Permanente Medical Center
Honolulu, Hawaii, 96819
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Methodist Hospital
Houston, Texas, 77030
Texas Heart Institute
Houston, Texas, 77030
VA Medical Center - Houston
Houston, Texas, 77030
Gulf Bay Cardiovascular and Thoracic Associates
Hudson, Florida, 34563
Community Hospital
Indianapolis, Indiana, 46219
St. Vincent's Medical Center
Indianapolis, Indiana, 46260
Apex Cardiology
Inglewood, California, 90301
University of Iowa
Iowa City, Iowa, 52242
Mississippi Center for Clinical Research
Jackson, Mississippi, 32216
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United Health Services
Johnson City, New York, 13790
University of Kansas City Medical Center
Kansas City, Kansas, 66160-7378
St. Luke's Hospital - Mid-America Heart Institute
Kansas City, Missouri, 64111
Gundersen-Lutheran Hospital
La Crosse, Wisconsin, 54601
Thoracic and Cardiovascular Institute
Lansing, Michigan, 48919
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Arkansas
Little Rock, Arkansas, 72205
Huntington Memorial Hospital
Los Angeles, California, 90033
University of Southern California
Los Angeles, California, 90033
St. Vincent's Hospital
Los Angeles, California, 90057
University of California - Los Angeles
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40202
University of Louisville
Louisville, Kentucky, 40292
Texas Tech University Health Center
Lubbock, Texas, 79430
VA Medical Center - Dubin
Macon, Georgia, 31208
MIMA Century Research Associates
Melbourne, Florida, 32901
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Brevard Cardiology Group, PA
Merritt Island, Florida, 32953
Desert Samaritan - Lutheran Heart
Mesa, Arizona, 85202
Medical Research Unlimited
Miami, Florida, 33125
Wisconsin Center for Clinical Research
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53295
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Park Nicollet Medical Center
Minneapolis, Minnesota, 55416
IMC-Diagnostic and Medical Clinic
Mobile, Alabama, 36604
West Shore Cardiology Research Department
Muskegon, Michigan, 46444
Turuo Infirmary
New Orleans, Louisiana, 70115
Methodist Hospital
New Orleans, Louisiana, 70118
Alton Ochsner Medical Foundation - Brent House
New Orleans, Louisiana, 70121
New York Presbyterian Hospital
New York, New York, 10021
Christiana Care Health Services
Newark, Delaware, 19718
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Parkway Cardiovascular Associates
Oak Ridge, Tennessee, 37830
Crozer-Chester Medical Center
Oakland, California, 94609-3102
Tri-City Medical Center
Oceanside, California, 92056
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73104
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Florida Heart Institute at Florida Hospital
Orlando, Florida, 32803
Orlando Heart Center
Orlando, Florida, 32806
Garden State Cardiology
Paramus, New Jersey, 07652
Cardiology Consultants
Pensacola, Florida, 32504
Ford Research Center
Pensacola, Florida, 32514
North Memorial Pain Institute
Philadelphia, Pennsylvania, 19102
Good Samaritan Regional Medical Center
Phoenix, Arizona, 85006
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Northwest Surgical Associates
Portland, Oregon, 97210
Legacy Good Samaritan Hospital
Portland, Oregon, 97232
Carillion Roanoke Hospital
Roanoke, Virginia, 24014
North Memorial Hospital
Robbinsdale, Minnesota, 55422
Rochester General Hospital
Rochester, New York, 14621
University of Rochester
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
Mercy General Hospital
Sacramento, California, 95819
Covenant Medical Center
Saginaw, Michigan, 48602
Park Nicollet Health Research Center
Saint Louis Park, Minnesota, 55426
South Texas Cardiovascular Consultants Clinical Research Center
San Antonio, Texas, 78229
South Texas VA Health Care
San Antonio, Texas, 78284
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284
San Diego Cardiac Center
San Diego, California, 92123
Kaiser Foundation Hospital
San Francisco, California, 94115
UCSF Moffitt-Long Hospital
San Francisco, California, 94143
North Ohio Heart Center
Sandusky, Ohio, 44870
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Guthrie Clinical Research
Sayre, Pennsylvania, 18840
VA-Medical Center -Seattle Cardiology
Seattle, Washington, 98108
University of Washington
Seattle, Washington, 98195
Cardiac Centers of Louisiana
Shreveport, Louisiana, 711033
Baystate Medical Center
Springfield, Massachusetts, 01199
Christian North East Hospital
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Northside Hospital ans Heart Institute
St. Petersburg, Florida, 33709
FHS Research Center
Tacoma, Washington, 98405
Tacoma General Hospital
Tacoma, Washington, 98405
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Tallahassee Memorial Regional Medical Center
Tallahassee, Florida, 32308
Pepin Heart and Vascular Institute
Tampa, Florida, 33613
Scott and White Memorial Hospital
Temple, Texas, 76508
Albert Einstein Hospital
The Bronx, New York, 10461
Cardiovascular Institute of the South
Thibodaux, Louisiana, 70301
Midatlantic Cardiovascular Associates
Towson, Maryland, 21204
St. Joseph's Hospital
Towson, Maryland, 21204
Saguaro Clinical Research
Tucson, Arizona, 85712
Southern Arizona VAMC
Tucson, Arizona, 85723
University of Arizona
Tucson, Arizona, 85724
Westchester County Medical Center
Valhalla, New York, 10595
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Cardiology Associates
Washington D.C., District of Columbia, 20010
Washington Hospital Center
Washington D.C., District of Columbia, 20010
VA Medical Center - Washington DC
Washington D.C., District of Columbia, 20422
Cardiovascular Research and Education Foundation, Inc.
Wausau, Wisconsin, 54401
Chester County Cardiovascular Center
West Chester, Pennsylvania, 19380
Wesley Medical Center
Wichita, Kansas, 67214
West forest School of Medicine
Winston-Salem, North Carolina, 27157
University of Massachusetts
Worcester, Massachusetts, 01655
Canada18 sites
Cathy Metcalfe Research Consultants
Delta, British Columbia, B4K 2G5
Makenzie Health Science Center
Edmonton, Alberta, T6G 2B7
Dalhousie University
Halifax, Nova Scotia, B3H 3A7
McMaster Clinic
Hamilton, Ontario, L8L 2X2
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
University of Montreal
Montreal, Quebec, H2L 4M1
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Hopital Laval
Québec, Quebec, G1V 4G5
Regina General Hospital
Regina, Saskatchewan, S4P 0W5
New Brunswick Heart Center
Saint John, New Brunswick, E2L 4L2
General Hospital Health Science Center
St. John's, Newfoundland and Labrador, A1B 3V6
Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, M4N 3M5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1C6
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Victoria Heart Institute
Victoria, British Columbia, V8R 4R2
University of Manitoba Health Science Centre
Winnipeg, Manitoba, R2H 2A6
Health Science Centre
Winnipeg, Manitoba, R3E 0Z3
About this study
During a heart bypass procedure, a substance called "complement" is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, heart failure, or impairment of memory, language and motor skills. The purpose of this study is to find out if the study drug (pexelizumab), which blocks complement release, can reduce such side effects and be taken safely.
- Being tested
- pexelizumab
- Keywords
- CABG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pexelizumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2002 (estimated)
- Study startJan 2002
- Primary completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-pulmonary BypassStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 3,000 participants
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048308
- Sponsor's protocol ID
- 2000099
- Other IDs
- PRIMO-CABG
- Status last verified
- Feb 2017
- First submitted
- 29 Oct 2002
- Last updated
- 23 Feb 2017
- Results posted
- No