Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)
A Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study of Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)
1 other identifier
interventional
4,000
4 countries
188
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 coronary-artery-disease
Started Jul 2004
Shorter than P25 for phase_3 coronary-artery-disease
188 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 21, 2004
CompletedFirst Posted
Study publicly available on registry
July 23, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFebruary 22, 2018
February 1, 2018
1.3 years
July 21, 2004
February 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction in mortality.
Reduction in MI incidence.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alexion Pharmaceuticals, Inc.lead
- Procter and Gamblecollaborator
Study Sites (188)
Brookwood Medical Center
Birmingham, Alabama, 35209, United States
Baptist Medical Center Princeton
Birmingham, Alabama, 35211, United States
Baptist Health Systems Montclair
Birmingham, Alabama, 35213, United States
Medical Center East Hospital
Birmingham, Alabama, 35235, United States
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35249-6810, United States
Thomas Hospital
Fairhope, Alabama, 36532, United States
Huntsville Hospital
Huntsville, Alabama, 35801, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
University Medical Center
Tucson, Arizona, 85724, United States
Southern Arizona Veterans Affairs Health Care System
Tucson, Arizona, 85732, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901, United States
Baptist Medical Center
Little Rock, Arkansas, 72205, United States
Bakersfield Heart Hospital
Bakersfield, California, 93301, United States
Seaton Medical Center
Daly City, California, 94015, United States
Palomar Medical Center
Escondido, California, 92025, United States
Saddleback Memorial Medical Center
Laguna Hills, California, 92653, United States
Los Angeles County-University of Southern California Medical Center
Los Angeles, California, 90033, United States
University of Southern California University Hospital
Los Angeles, California, 90033, United States
St. Vincent Medical Center
Los Angeles, California, 90057, United States
Veterans Administration Greater Los Angeles Healthcare Sysytem
Los Angeles, California, 90073, United States
Tri City Medical Center
Oceanside, California, 92056, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Veterans Administration Palo Alto Healthcare System
Palo Alto, California, 94304, United States
Huntington Memorial Hospital
Pasadena, California, 91105, United States
Mercy General Hospital
Sacramento, California, 95819, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Kaiser Permanente Medical Center
San Francisco, California, 94115, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Presbyterian St.Luke's Medical Center
Denver, Colorado, 80218, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
St. Vincent's Medical Center
Bridgeport, Connecticut, 06606, United States
Hospital of Saint Raphael
New Haven, Connecticut, 06511, United States
Christiana Hospital
Newark, Delaware, 19718, United States
John F. Kennedy Medical Center
Atlantis, Florida, 33462, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Halifax Medical Center
Daytona Beach, Florida, 32114, United States
North Ridge Medical Center
Fort Lauderdale, Florida, 33334, United States
Shands Hospital at the University of Florida
Gainesville, Florida, 32610, United States
Regional Medical Center Bayonet Point
Hudson, Florida, 34667, United States
Baptist Medical Center
Jacksonville, Florida, 32207, United States
Memorial Hospital
Jacksonville, Florida, 32216, United States
Lakeland Regional Medical Center
Lakeland, Florida, 33805, United States
Health First Holmes Regional Medical Center
Melbourne, Florida, 32901, United States
Orlando Regional Medical Center
Orlando, Florida, 32801, United States
Florida Hospital
Orlando, Florida, 32803, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Wuesthoff Hospital
Rockledge, Florida, 32955, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Northside Hospital and Heart Institute
St. Petersburg, Florida, 33701, United States
University Community Hospital
Tampa, Florida, 33613, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Atlanta Veteran's Administration (VA) Medical Center
Decatur, Georgia, 30033, United States
Medical Center of Central Georgia
Macon, Georgia, 31208, United States
St. Joseph's/Candler Health System
Savannah, Georgia, 31404, United States
St. Joseph's/Candler Health System
Savannah, Georgia, 31419, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Memorial Medical Center
Springfield, Illinois, 62702, United States
St. John's Hospital
Springfield, Illinois, 62769, United States
Indiana Ohio Heart
Fort Wayne, Indiana, 46804, United States
Clarian Health Partners, Inc. Methodist Hospital
Indianapolis, Indiana, 46202, United States
The Indiana Heart Hospital
Indianapolis, Indiana, 46250, United States
The Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
Olathe Medical Center
Olathe, Kansas, 66061, United States
Galichia Heart Hospital
Wichita, Kansas, 67202, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Veterans Affairs Medical Center
Lexington, Kentucky, 40506, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Norton Hospital
Louisville, Kentucky, 40202, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Terrebonne General Medical Center
Houma, Louisiana, 70360, United States
Louisiana Heart Hospital
Lacombe, Louisiana, 70445, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112, United States
Oschner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Pendleton Memorial Methodist Hospital
New Orleans, Louisiana, 70127, United States
Touro Infirmary
New Orleans, Louisiana, United States
Slidell Memorial Hospital
Slidell, Louisiana, 70458, United States
Maine Medical Center
Portland, Maine, 04102, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Peninusla Medical Center
Salisbury, Maryland, 21801, United States
St. Joseph Medical Center
Towson, Maryland, 21204, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Veterans Administration (VA) Boston Healthcare System
West Roxbury, Massachusetts, 02132, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
McLaren Regional Medical Center
Flint, Michigan, 48532, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Ingham Regional Medical Center
Lansing, Michigan, 48910, 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, 48601, United States
Mayo Clinic College of Medicine
Rochester, Minnesota, 55905, United States
St. Luke's Health System
Kansas City, Missouri, 64111, United States
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Saint Louis University
St Louis, Missouri, 63110, United States
Des Peres Hospital
St Louis, Missouri, 63122, United States
Nebraska Heart Hospital
Lincoln, Nebraska, 68506, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08035, United States
Cooper Health System/University Medical Center
Camden, New Jersey, 08103, United States
Our Lady Of Lourdes Medical Center
Camden, New Jersey, 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956, United States
Maimondes Medical Center
Brooklyn, New York, 11219, United States
United Health Services Hospital
Johnson City, New York, 13790, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601, United States
Rochester General Hospital
Rochester, New York, 14621, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
University of North Carolina at Chapel Hill Hospitals
Chapel Hill, North Carolina, 27599-7075, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
Pitt County Memorial Hospital
Greenville, North Carolina, 27858, United States
Medcenter One
Bismarck, North Dakota, 58501, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0542, United States
University Hospitals Health System
Cleveland, Ohio, 44106-5011, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
The Dayton Heart Hospital
Dayton, Ohio, 45408, United States
The Toledo Hospital
Toledo, Ohio, 43606, United States
Good Samaritan Hospital
Zanesville, Ohio, 43701, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
St. Charles Medical Center
Bend, Oregon, 97701, United States
Legacy Good Samaritan Hospital
Portland, Oregon, 97210, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19067, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102, United States
Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Crozer Chester Medical Center
Upland, Pennsylvania, 19013, United States
The Chester County Hospital
West Chester, Pennsylvania, 19380, United States
Roper St. Francis Healthcare
Charleston, South Carolina, 29401, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
The Chattanooga Heart Institute
Chattanooga, Tennessee, 37404, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
Baptist Hospital
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8815, United States
Methodist Medical Center
Oak Ridge, Tennessee, 37830, United States
Heart Hospital of Austin
Austin, Texas, 78756, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Christus Saint Joseph Hospital
Houston, Texas, 77002, United States
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030-4298, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Methodist Hospital
Houston, Texas, 77030, United States
St. Luke's Episcopal Hospital - Texas Heart
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Covenant Medical Center
Lubbock, Texas, 79410, United States
TexSan Heart Hospital
San Antonio, Texas, 78201, United States
Northeast Baptist Hospital
San Antonio, Texas, 78217, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Virginia Hospital Center
Arlington, Virginia, 22205, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3300, United States
Memorial Regional Medical Center
Mechanicsville, Virginia, 23116, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
CJW Medical Center
Richmond, Virginia, 23225, United States
Henrico Doctors' Hospital
Richmond, Virginia, 23229, United States
University of Washington Medical Center
Seattle, Washington, 98195-6310, United States
Saint Joseph Medical Center
Tacoma, Washington, 98405, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Hopital Minjoz
Besançon, 25030, France
Hopital du Bocage
Dijon, 21031, France
Hopital Albert Michallon
Grenoble, 38043, France
Hopital Europeen Georges Pompidou
Paris, 75908, France
Zentrum fuer Herzchirurgie der Frederick-Alexander-Universitaet
Erlangen, 91054, Germany
Leiden University Medical Center
Leiden, 2333, Netherlands
Related Publications (1)
Smith PK, Shernan SK, Chen JC, Carrier M, Verrier ED, Adams PX, Todaro TG, Muhlbaier LH, Levy JH; PRIMO-CABG II Investigators. Effects of C5 complement inhibitor pexelizumab on outcome in high-risk coronary artery bypass grafting: combined results from the PRIMO-CABG I and II trials. J Thorac Cardiovasc Surg. 2011 Jul;142(1):89-98. doi: 10.1016/j.jtcvs.2010.08.035. Epub 2010 Sep 28.
PMID: 20880552DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter X Adams, MD
Alexion Pharmaceuticals, Inc.
- STUDY CHAIR
Edward Verrier, MD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 21, 2004
First Posted
July 23, 2004
Study Start
July 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
February 22, 2018
Record last verified: 2018-02