Clinical trial NCT00048308: Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardio-pulmonary Bypass
Coronary Artery Bypass Graft
Keywords: CABG
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2002-10-31
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

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