Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00088179
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Brief Summary
During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4000
-
be at least 18 years of age;
-
have 2 or more of the following risk factors:
• diabetes mellitus; • repeat CABG; • the need for urgent intervention, defined according to the ACC/AHA guidelines as being patients who are required to stay in the hospital due to medical factors, but may be scheduled and operated on within a normal scheduling routine, excluding patients who have had an 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 (NYHA CHF Class III or IV); • history of 2 MIs, or an MI that occurred greater than 48 hours but less than 4 weeks prior to CABG;
-
provide Informed Consent.
- requires salvage intervention as defined by the ACC/AHA guidelines 10 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 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 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 within 30 days of randomization;
- is pregnant or breast-feeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction in mortality. Reduction in MI incidence.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (184)
Bakersfield Heart Hospital
🇺🇸Bakersfield, California, United States
St. Vincent's Medical Center
🇺🇸Bridgeport, Connecticut, United States
Medical Center of Central Georgia
🇺🇸Macon, Georgia, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University Hospitals Health System
🇺🇸Cleveland, Ohio, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
St. Luke's Episcopal Hospital - Texas Heart
🇺🇸Houston, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
The Indiana Heart Hospital
🇺🇸Indianapolis, Indiana, United States
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
TexSan Heart Hospital
🇺🇸San Antonio, Texas, United States
Northeast Baptist Hospital
🇺🇸San Antonio, Texas, United States
Galichia Heart Hospital
🇺🇸Wichita, Kansas, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Baptist Hospital
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Baptist Medical Center Princeton
🇺🇸Birmingham, Alabama, United States
Medical Center East Hospital
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Presbyterian St.Luke's Medical Center
🇺🇸Denver, Colorado, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Mayo Clinic College of Medicine
🇺🇸Rochester, Minnesota, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
University of Southern California University Hospital
🇺🇸Los Angeles, California, United States
University of California Irvine Medical Center
🇺🇸Orange, California, United States
Los Angeles County-University of Southern California Medical Center
🇺🇸Los Angeles, California, United States
St. Vincent Medical Center
🇺🇸Los Angeles, California, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
Palomar Medical Center
🇺🇸Escondido, California, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
Memorial Hospital
🇺🇸Jacksonville, Florida, United States
Regional Medical Center Bayonet Point
🇺🇸Hudson, Florida, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Christiana Hospital
🇺🇸Newark, Delaware, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
North Ridge Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Indiana Ohio Heart
🇺🇸Fort Wayne, Indiana, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Northside Hospital and Heart Institute
🇺🇸Saint Petersburg, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Olathe Medical Center
🇺🇸Olathe, Kansas, United States
McLaren Regional Medical Center
🇺🇸Flint, Michigan, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Covenant Medical Center
🇺🇸Lubbock, Texas, United States
Our Lady Of Lourdes Medical Center
🇺🇸Camden, New Jersey, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
Cooper Health System/University Medical Center
🇺🇸Camden, New Jersey, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Maimondes Medical Center
🇺🇸Brooklyn, New York, United States
Cooper Hospital University Medical Center
🇺🇸Camden, New Jersey, United States
Medcenter One
🇺🇸Bismarck, North Dakota, United States
Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Moses H. Cone Memorial Hospital
🇺🇸Greensboro, North Carolina, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Christus Saint Joseph Hospital
🇺🇸Houston, Texas, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Methodist Medical Center
🇺🇸Oak Ridge, Tennessee, United States
Hopital du Bocage
🇫🇷Dijon, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Hopital Albert Michallon
🇫🇷Grenoble, France
Des Peres Hospital
🇺🇸Saint Louis, Missouri, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
West Shore Cardiology Research Department
🇺🇸Muskegon, Michigan, United States
Brookwood Medical Center
🇺🇸Birmingham, Alabama, United States
Baptist Health Systems Montclair
🇺🇸Birmingham, Alabama, United States
Huntsville Hospital
🇺🇸Huntsville, Alabama, United States
Thomas Hospital
🇺🇸Fairhope, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
University Medical Center
🇺🇸Tucson, Arizona, United States
Sparks Regional Medical Center
🇺🇸Fort Smith, Arkansas, United States
Seaton Medical Center
🇺🇸Daly City, California, United States
Veterans Administration Greater Los Angeles Healthcare Sysytem
🇺🇸Los Angeles, California, United States
Kaiser Permanente Medical Center
🇺🇸San Francisco, California, United States
Tri City Medical Center
🇺🇸Oceanside, California, United States
Veterans Administration Palo Alto Healthcare System
🇺🇸Palo Alto, California, United States
John F. Kennedy Medical Center
🇺🇸Atlantis, Florida, United States
Halifax Medical Center
🇺🇸Daytona Beach, Florida, United States
Health First Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Wuesthoff Hospital
🇺🇸Rockledge, Florida, United States
St. Joseph's/Candler Health System
🇺🇸Savannah, Georgia, United States
Atlanta Veteran's Administration (VA) Medical Center
🇺🇸Decatur, Georgia, United States
Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Clarian Health Partners, Inc. Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
The Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Louisiana Heart Hospital
🇺🇸Lacombe, Louisiana, United States
Terrebonne General Medical Center
🇺🇸Houma, Louisiana, United States
Peninusla Medical Center
🇺🇸Salisbury, Maryland, United States
Slidell Memorial Hospital
🇺🇸Slidell, Louisiana, United States
Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Veterans Administration (VA) Boston Healthcare System
🇺🇸West Roxbury, Massachusetts, United States
Spectrum Health Hospitals
🇺🇸Grand Rapids, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Nebraska Heart Hospital
🇺🇸Lincoln, Nebraska, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
United Health Services Hospital
🇺🇸Johnson City, New York, United States
Vassar Brothers Medical Center
🇺🇸Poughkeepsie, New York, United States
Pitt County Memorial Hospital
🇺🇸Greenville, North Carolina, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
The Dayton Heart Hospital
🇺🇸Dayton, Ohio, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
INTEGRIS Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
St. Charles Medical Center
🇺🇸Bend, Oregon, United States
Legacy Good Samaritan Hospital
🇺🇸Portland, Oregon, United States
St. Mary Medical Center
🇺🇸Langhorne, Pennsylvania, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Crozer Chester Medical Center
🇺🇸Upland, Pennsylvania, United States
The Chester County Hospital
🇺🇸West Chester, Pennsylvania, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
The Chattanooga Heart Institute
🇺🇸Chattanooga, Tennessee, United States
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Virginia Hospital Center
🇺🇸Arlington, Virginia, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Memorial Regional Medical Center
🇺🇸Mechanicsville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Saint Joseph Medical Center
🇺🇸Tacoma, Washington, United States
Hopital Minjoz
🇫🇷Besancon, France
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Zentrum fuer Herzchirurgie der Frederick-Alexander-Universitaet
🇩🇪Erlangen, Germany
Southern Arizona Veterans Affairs Health Care System
🇺🇸Tucson, Arizona, United States
Saddleback Memorial Medical Center
🇺🇸Laguna Hills, California, United States
Michael E. DeBakey Veterans Affairs Medical Center
🇺🇸Houston, Texas, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Hospital of Saint Raphael
🇺🇸New Haven, Connecticut, United States
Shands Hospital at the University of Florida
🇺🇸Gainesville, Florida, United States
Orlando Regional Medical Center
🇺🇸Orlando, Florida, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
University Community Hospital
🇺🇸Tampa, Florida, United States
Kaiser Permanente Moanalua Medical Center
🇺🇸Honolulu, Hawaii, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center
🇺🇸Lexington, Kentucky, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Norton Hospital
🇺🇸Louisville, Kentucky, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
St. Luke's Health System
🇺🇸Kansas City, Missouri, United States
Oschner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Touro Infirmary
🇺🇸New Orleans, Louisiana, United States
CJW Medical Center
🇺🇸Richmond, Virginia, United States
Pendleton Memorial Methodist Hospital
🇺🇸New Orleans, Louisiana, United States
Roper St. Francis Healthcare
🇺🇸Charleston, South Carolina, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States
University of North Carolina at Chapel Hill Hospitals
🇺🇸Chapel Hill, North Carolina, United States
Henrico Doctors' Hospital
🇺🇸Richmond, Virginia, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States