Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass
2 other identifiers
interventional
3,000
2 countries
186
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
186 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 29, 2002
CompletedFirst Posted
Study publicly available on registry
October 31, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedFebruary 23, 2017
February 1, 2017
1.2 years
October 29, 2002
February 21, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (186)
Baptist Medical Center Cardiology
Birmingham, Alabama, 35211, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249-6880, United States
IMC-Diagnostic and Medical Clinic
Mobile, Alabama, 36604, United States
Desert Samaritan - Lutheran Heart
Mesa, Arizona, 85202, United States
Good Samaritan Regional Medical Center
Phoenix, Arizona, 85006, United States
Saguaro Clinical Research
Tucson, Arizona, 85712, United States
Southern Arizona VAMC
Tucson, Arizona, 85723, United States
University of Arizona
Tucson, Arizona, 85724, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901, United States
University of Arkansas
Little Rock, Arkansas, 72205, United States
Brotman Medical Center
Beverly Hills, California, 90210, United States
Cardiovascular Associates of the Peninsula
Burlingame, California, 94401, United States
Seton Medical Center
Daly City, California, 94015, United States
St. Jude Medical Center
Fullerton, California, 92835, United States
Apex Cardiology
Inglewood, California, 90301, United States
Huntington Memorial Hospital
Los Angeles, California, 90033, United States
University of Southern California
Los Angeles, California, 90033, United States
St. Vincent's Hospital
Los Angeles, California, 90057, United States
University of California - Los Angeles
Los Angeles, California, 90095, United States
Crozer-Chester Medical Center
Oakland, California, 94609-3102, United States
Tri-City Medical Center
Oceanside, California, 92056, United States
Mercy General Hospital
Sacramento, California, 95819, United States
San Diego Cardiac Center
San Diego, California, 92123, United States
Kaiser Foundation Hospital
San Francisco, California, 94115, United States
UCSF Moffitt-Long Hospital
San Francisco, California, 94143, United States
South Denver Cardiology Associates
Denver, Colorado, 80111, United States
Western Cardiology Associates
Denver, Colorado, 80218, United States
Heart and Vascular Clinic of Northern CO
Fort Collins, Colorado, 80528, United States
St. Vincent's Medical Center
Bridgeport, Connecticut, 06606, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Christiana Care Health Services
Newark, Delaware, 19718, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Cardiology Associates
Washington D.C., District of Columbia, 20010, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
VA Medical Center - Washington DC
Washington D.C., District of Columbia, 20422, United States
Florida Cardiovascular Research
Atlantis, Florida, 33462, United States
Morton Plan Mease Health Care
Clearwater, Florida, 33756, United States
Heart Group Research
Fort Lauderdale, Florida, 33308, United States
Gulf Bay Cardiovascular and Thoracic Associates
Hudson, Florida, 34563, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
MIMA Century Research Associates
Melbourne, Florida, 32901, United States
Brevard Cardiology Group, PA
Merritt Island, Florida, 32953, United States
Medical Research Unlimited
Miami, Florida, 33125, United States
Florida Heart Institute at Florida Hospital
Orlando, Florida, 32803, United States
Orlando Heart Center
Orlando, Florida, 32806, United States
Cardiology Consultants
Pensacola, Florida, 32504, United States
Ford Research Center
Pensacola, Florida, 32514, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Northside Hospital ans Heart Institute
St. Petersburg, Florida, 33709, United States
Tallahassee Memorial Regional Medical Center
Tallahassee, Florida, 32308, United States
Pepin Heart and Vascular Institute
Tampa, Florida, 33613, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
St. Joseph's Hospital
Atlanta, Georgia, 30342, United States
University Hospital
Augusta, Georgia, 30901, United States
VA Medical Center- Atlanta
Decatur, Georgia, 30033, United States
VA Medical Center - Dubin
Macon, Georgia, 31208, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813-3009, United States
Kaiser Permanente Medical Center
Honolulu, Hawaii, 96819, United States
Northwestern Univ. Medical Center
Chicago, Illinois, 60611, United States
Northwestern University Medical Center
Chicago, Illinois, 60611, United States
University of Illinois - Chicago
Chicago, Illinois, 60612, United States
Evanston Northwestern Healthcare Evanston Hospital
Evanston, Illinois, 60201, United States
Indiana Ohio Heart
Fort Wayne, Indiana, 46804, United States
Community Hospital
Indianapolis, Indiana, 46219, United States
St. Vincent's Medical Center
Indianapolis, Indiana, 46260, United States
Iowa Heart Center - Laurel
Des Moines, Iowa, 50314, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas City Medical Center
Kansas City, Kansas, 66160-7378, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
University of Louisville
Louisville, Kentucky, 40202, United States
University of Louisville
Louisville, Kentucky, 40292, United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
Turuo Infirmary
New Orleans, Louisiana, 70115, United States
Methodist Hospital
New Orleans, Louisiana, 70118, United States
Alton Ochsner Medical Foundation - Brent House
New Orleans, Louisiana, 70121, United States
Cardiac Centers of Louisiana
Shreveport, Louisiana, 711033, United States
Cardiovascular Institute of the South
Thibodaux, Louisiana, 70301, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
Midatlantic Cardiovascular Associates
Towson, Maryland, 21204, United States
St. Joseph's Hospital
Towson, Maryland, 21204, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
McLaren Regional Medical Center
Flint, Michigan, 48532, United States
Thoracic and Cardiovascular Institute
Lansing, Michigan, 48919, United States
West Shore Cardiology Research Department
Muskegon, Michigan, 46444, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Covenant Medical Center
Saginaw, Michigan, 48602, United States
St. Luke's Hospital-Duluth
Duluth, Minnesota, 55805, United States
St. Mary's Duluth Health System
Duluth, Minnesota, 55805, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Park Nicollet Medical Center
Minneapolis, Minnesota, 55416, United States
North Memorial Hospital
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Health Research Center
Saint Louis Park, Minnesota, 55426, United States
Mississippi Center for Clinical Research
Jackson, Mississippi, 32216, United States
Cardiology diagnostics, Ltd.
City of Saint Peters, Missouri, 63376, United States
St. Luke's Hospital - Mid-America Heart Institute
Kansas City, Missouri, 64111, United States
Christian North East Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035, United States
Garden State Cardiology
Paramus, New Jersey, 07652, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
United Health Services
Johnson City, New York, 13790, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
Rochester General Hospital
Rochester, New York, 14621, United States
University of Rochester
Rochester, New York, 14642, United States
Albert Einstein Hospital
The Bronx, New York, 10461, United States
Westchester County Medical Center
Valhalla, New York, 10595, United States
Asheville Cardiothoracic Surgeons
Asheville, North Carolina, 28803, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
West forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Summa Health Systems
Akron, Ohio, 44309, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45219, United States
Sterling Research Group
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital -Seton Center
Cincinnati, Ohio, 45220, United States
Tri Health Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
University Hopital of Cleveland
Cleveland, Ohio, 44106, United States
Mt. Carmel West
Columbus, Ohio, 43222, United States
Dayton Heart Center
Dayton, Ohio, 45414, United States
North Ohio Heart Center
Sandusky, Ohio, 44870, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Northwest Surgical Associates
Portland, Oregon, 97210, United States
Legacy Good Samaritan Hospital
Portland, Oregon, 97232, United States
The Heart Center
Doylestown, Pennsylvania, 18901, United States
North Memorial Pain Institute
Philadelphia, Pennsylvania, 19102, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Guthrie Clinical Research
Sayre, Pennsylvania, 18840, United States
Chester County Cardiovascular Center
West Chester, Pennsylvania, 19380, United States
The Chattanooga Heart Institute Cardiovascular Group, P.C.
Chattanooga, Tennessee, 37404, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
Parkway Cardiovascular Associates
Oak Ridge, Tennessee, 37830, United States
Brackenridge Hospital
Austin, Texas, 78701, United States
Seton Medical Center
Austin, Texas, 78705, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Methodist Hospital
Houston, Texas, 77030, United States
Texas Heart Institute
Houston, Texas, 77030, United States
VA Medical Center - Houston
Houston, Texas, 77030, United States
Texas Tech University Health Center
Lubbock, Texas, 79430, United States
South Texas Cardiovascular Consultants Clinical Research Center
San Antonio, Texas, 78229, United States
South Texas VA Health Care
San Antonio, Texas, 78284, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Cardiovascular and Thoracic Surgery Associates
Arlington, Virginia, 22205, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22043, United States
Mary Washington Hospital
Fredericksburg, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Carillion Roanoke Hospital
Roanoke, Virginia, 24014, United States
VA-Medical Center -Seattle Cardiology
Seattle, Washington, 98108, United States
University of Washington
Seattle, Washington, 98195, United States
FHS Research Center
Tacoma, Washington, 98405, United States
Tacoma General Hospital
Tacoma, Washington, 98405, United States
Camcare Health Education & Research Institute
Charleston, West Virginia, 25304, United States
Appleton Medical Center
Appleton, Wisconsin, 54911, United States
Gundersen-Lutheran Hospital
La Crosse, Wisconsin, 54601, United States
Wisconsin Center for Clinical Research
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53295, United States
Cardiovascular Research and Education Foundation, Inc.
Wausau, Wisconsin, 54401, United States
Makenzie Health Science Center
Edmonton, Alberta, T6G 2B7, Canada
Cathy Metcalfe Research Consultants
Delta, British Columbia, B4K 2G5, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1C6, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Victoria Heart Institute
Victoria, British Columbia, V8R 4R2, Canada
University of Manitoba Health Science Centre
Winnipeg, Manitoba, R2H 2A6, Canada
Health Science Centre
Winnipeg, Manitoba, R3E 0Z3, Canada
New Brunswick Heart Center
Saint John, New Brunswick, E2L 4L2, Canada
General Hospital Health Science Center
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Dalhousie University
Halifax, Nova Scotia, B3H 3A7, Canada
McMaster Clinic
Hamilton, Ontario, L8L 2X2, Canada
Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, M4N 3M5, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
University of Montreal
Montreal, Quebec, H2L 4M1, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Hopital Laval
Québec, Quebec, G1V 4G5, Canada
Regina General Hospital
Regina, Saskatchewan, S4P 0W5, Canada
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2002
First Posted
October 31, 2002
Study Start
January 1, 2002
Primary Completion
March 1, 2003
Last Updated
February 23, 2017
Record last verified: 2017-02