Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass

Coronary Artery Bypass Graft Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048308
• Other study ID #: 2000099
• Secondary ID: PRIMO-CABG
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2002
• Last updated: February 21, 2017
• Start date: January 2002

Study information

• Verified date: February 2017
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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;

• 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.

Related Conditions & MeSH terms

• Cardio-pulmonary Bypass
• Coronary Artery Bypass Graft

Intervention

Drug:
• pexelizumab

Locations

Country	Name	City	State
Canada	Cathy Metcalfe Research Consultants	Delta	British Columbia
Canada	Makenzie Health Science Center	Edmonton	Alberta
Canada	Dalhousie University	Halifax	Nova Scotia
Canada	McMaster Clinic	Hamilton	Ontario
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	University of Montreal	Montreal	Quebec
Canada	Hopital Laval	Quebec City	Quebec
Canada	Regina General Hospital	Regina	Saskatchewan
Canada	New Brunswick Heart Center	St. John	New Brunswick
Canada	General Hospital Health Science Center	St. John's	Newfoundland and Labrador
Canada	Sunnybrook & Women's College Health Science Centre	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Victoria Heart Institute	Victoria	British Columbia
Canada	Health Science Centre	Winnipeg	Manitoba
Canada	University of Manitoba Health Science Centre	Winnipeg	Manitoba
United States	Akron General Medical Center	Akron	Ohio
United States	Summa Health Systems	Akron	Ohio
United States	Appleton Medical Center	Appleton	Wisconsin
United States	Cardiovascular and Thoracic Surgery Associates	Arlington	Virginia
United States	Asheville Cardiothoracic Surgeons	Asheville	North Carolina
United States	Emory University Hospital	Atlanta	Georgia
United States	St. Joseph's Hospital	Atlanta	Georgia
United States	Florida Cardiovascular Research	Atlantis	Florida
United States	University Hospital	Augusta	Georgia
United States	Brackenridge Hospital	Austin	Texas
United States	Seton Medical Center	Austin	Texas
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Union Memorial Hospital	Baltimore	Maryland
United States	Bend Memorial Clinic	Bend	Oregon
United States	Brotman Medical Center	Beverly Hills	California
United States	Baptist Medical Center Cardiology	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	St. Vincent's Medical Center	Bridgeport	Connecticut
United States	Albert Einstein Hospital	Bronx	New York
United States	Maimonides Medical Center	Brooklyn	New York
United States	Cardiovascular Associates of the Peninsula	Burlingame	California
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Camcare Health Education & Research Institute	Charleston	West Virginia
United States	The Chattanooga Heart Institute Cardiovascular Group, P.C.	Chattanooga	Tennessee
United States	Northwestern Univ. Medical Center	Chicago	Illinois
United States	Northwestern University Medical Center	Chicago	Illinois
United States	University of Illinois - Chicago	Chicago	Illinois
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Good Samaritan Hospital -Seton Center	Cincinnati	Ohio
United States	Sterling Research Group	Cincinnati	Ohio
United States	Tri Health Bethesda North Hospital	Cincinnati	Ohio
United States	Morton Plan Mease Health Care	Clearwater	Florida
United States	University Hopital of Cleveland	Cleveland	Ohio
United States	Mt. Carmel West	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Seton Medical Center	Daly City	California
United States	Dayton Heart Center	Dayton	Ohio
United States	VA Medical Center- Atlanta	Decatur	Georgia
United States	South Denver Cardiology Associates	Denver	Colorado
United States	Western Cardiology Associates	Denver	Colorado
United States	Iowa Heart Center - Laurel	Des Moines	Iowa
United States	Henry Ford Hospital	Detroit	Michigan
United States	The Heart Center	Doylestown	Pennsylvania
United States	St. Luke's Hospital-Duluth	Duluth	Minnesota
United States	St. Mary's Duluth Health System	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	Evanston Northwestern Healthcare Evanston Hospital	Evanston	Illinois
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	McLaren Regional Medical Center	Flint	Michigan
United States	Heart and Vascular Clinic of Northern CO	Fort Collins	Colorado
United States	Heart Group Research	Fort Lauderdale	Florida
United States	Sparks Regional Medical Center	Fort Smith	Arkansas
United States	Indiana Ohio Heart	Fort Wayne	Indiana
United States	Mary Washington Hospital	Fredericksburg	Virginia
United States	St. Jude Medical Center	Fullerton	California
United States	Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey
United States	Kaiser Permanente Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital	Honolulu	Hawaii
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Methodist Hospital	Houston	Texas
United States	Texas Heart Institute	Houston	Texas
United States	VA Medical Center - Houston	Houston	Texas
United States	Gulf Bay Cardiovascular and Thoracic Associates	Hudson	Florida
United States	Community Hospital	Indianapolis	Indiana
United States	St. Vincent's Medical Center	Indianapolis	Indiana
United States	Apex Cardiology	Inglewood	California
United States	University of Iowa	Iowa City	Iowa
United States	Mississippi Center for Clinical Research	Jackson	Mississippi
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	United Health Services	Johnson City	New York
United States	St. Luke's Hospital - Mid-America Heart Institute	Kansas City	Missouri
United States	University of Kansas City Medical Center	Kansas City	Kansas
United States	Gundersen-Lutheran Hospital	La Crosse	Wisconsin
United States	Thoracic and Cardiovascular Institute	Lansing	Michigan
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Arkansas	Little Rock	Arkansas
United States	Huntington Memorial Hospital	Los Angeles	California
United States	St. Vincent's Hospital	Los Angeles	California
United States	University of California - Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	Texas Tech University Health Center	Lubbock	Texas
United States	VA Medical Center - Dubin	Macon	Georgia
United States	MIMA Century Research Associates	Melbourne	Florida
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Brevard Cardiology Group, PA	Merritt Island	Florida
United States	Desert Samaritan - Lutheran Heart	Mesa	Arizona
United States	Medical Research Unlimited	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Wisconsin Center for Clinical Research	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Park Nicollet Medical Center	Minneapolis	Minnesota
United States	IMC-Diagnostic and Medical Clinic	Mobile	Alabama
United States	West Shore Cardiology Research Department	Muskegon	Michigan
United States	Alton Ochsner Medical Foundation - Brent House	New Orleans	Louisiana
United States	Methodist Hospital	New Orleans	Louisiana
United States	Turuo Infirmary	New Orleans	Louisiana
United States	New York Presbyterian Hospital	New York City	New York
United States	Christiana Care Health Services	Newark	Delaware
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Parkway Cardiovascular Associates	Oak Ridge	Tennessee
United States	Crozer-Chester Medical Center	Oakland	California
United States	Tri-City Medical Center	Oceanside	California
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Oklahoma Foundation for Cardiovascular Research	Oklahoma City	Oklahoma
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Florida Heart Institute at Florida Hospital	Orlando	Florida
United States	Orlando Heart Center	Orlando	Florida
United States	Garden State Cardiology	Paramus	New Jersey
United States	Cardiology Consultants	Pensacola	Florida
United States	Ford Research Center	Pensacola	Florida
United States	North Memorial Pain Institute	Philadelphia	Pennsylvania
United States	Good Samaritan Regional Medical Center	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Legacy Good Samaritan Hospital	Portland	Oregon
United States	Northwest Surgical Associates	Portland	Oregon
United States	Carillion Roanoke Hospital	Roanoke	Virginia
United States	North Memorial Hospital	Robbinsdale	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	University of Rochester	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	Covenant Medical Center	Saginaw	Michigan
United States	South Texas Cardiovascular Consultants Clinical Research Center	San Antonio	Texas
United States	South Texas VA Health Care	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	San Diego Cardiac Center	San Diego	California
United States	Kaiser Foundation Hospital	San Francisco	California
United States	UCSF Moffitt-Long Hospital	San Francisco	California
United States	North Ohio Heart Center	Sandusky	Ohio
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Guthrie Clinical Research	Sayre	Pennsylvania
United States	University of Washington	Seattle	Washington
United States	VA-Medical Center -Seattle Cardiology	Seattle	Washington
United States	Cardiac Centers of Louisiana	Shreveport	Louisiana
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Christian North East Hospital	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Park Nicollet Health Research Center	St. Louis Park	Minnesota
United States	Cardiology diagnostics, Ltd.	St. Peters	Missouri
United States	Northside Hospital ans Heart Institute	St. Petersburg	Florida
United States	FHS Research Center	Tacoma	Washington
United States	Tacoma General Hospital	Tacoma	Washington
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Tallahassee Memorial Regional Medical Center	Tallahassee	Florida
United States	Pepin Heart and Vascular Institute	Tampa	Florida
United States	Scott and White Memorial Hospital	Temple	Texas
United States	Cardiovascular Institute of the South	Thibodaux	Louisiana
United States	Midatlantic Cardiovascular Associates	Towson	Maryland
United States	St. Joseph's Hospital	Towson	Maryland
United States	Saguaro Clinical Research	Tucson	Arizona
United States	Southern Arizona VAMC	Tucson	Arizona
United States	University of Arizona	Tucson	Arizona
United States	Westchester County Medical Center	Valhalla	New York
United States	Cardiology Associates	Washington	District of Columbia
United States	Georgetown University Hospital	Washington	District of Columbia
United States	VA Medical Center - Washington DC	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia
United States	Cardiovascular Research and Education Foundation, Inc.	Wausau	Wisconsin
United States	Chester County Cardiovascular Center	West Chester	Pennsylvania
United States	Wesley Medical Center	Wichita	Kansas
United States	West forest School of Medicine	Winston-Salem	North Carolina
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,