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Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00088179
Recruitment Status : Active, not recruiting
First Posted : July 23, 2004
Last Update Posted : February 16, 2017
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: pexelizumab in conjunction with CABG Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : July 2004
Primary Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Reduction in mortality.
  2. Reduction in MI incidence.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088179

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United States, Alabama
Brookwood Medical Center
Birmingham, Alabama, United States, 35209
Baptist Medical Center Princeton
Birmingham, Alabama, United States, 35211
Baptist Health Systems Montclair
Birmingham, Alabama, United States, 35213
Medical Center East Hospital
Birmingham, Alabama, United States, 35235
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35249-6810
Thomas Hospital
Fairhope, Alabama, United States, 36532
Huntsville Hospital
Huntsville, Alabama, United States, 35801
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Mobile, Alabama, United States, 36607
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Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
Southern Arizona Veterans Affairs Health Care System
Tucson, Arizona, United States, 85732
University Medical Center
Tuscon, Arizona, United States, 85724
United States, Arkansas
Sparks Regional Medical Center
Fort Smith, Arkansas, United States, 72901
Baptist Medical Center
Little Rock, Arkansas, United States, 72205
United States, California
Bakersfield Heart Hospital
Bakersfield, California, United States, 93301
Seaton Medical Center
Daly City, California, United States, 94015
Palomar Medical Center
Escondido, California, United States, 92025
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
Los Angeles County-University of Southern California Medical Center
Los Angeles, California, United States, 90033
University of Southern California University Hospital
Los Angeles, California, United States, 90033
St. Vincent Medical Center
Los Angeles, California, United States, 90057
Veterans Administration Greater Los Angeles Healthcare Sysytem
Los Angeles, California, United States, 90073
Tri City Medical Center
Oceanside, California, United States, 92056
University of California Irvine Medical Center
Orange, California, United States, 92868
Veterans Administration Palo Alto Healthcare System
Palo Alto, California, United States, 94304
Huntington Memorial Hospital
Pasadena, California, United States, 91105
Mercy General Hospital
Sacramento, California, United States, 95819
Sharp Memorial Hospital
San Diego, California, United States, 92123
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San Francisco, California, United States, 94115
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Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian St.Luke's Medical Center
Denver, Colorado, United States, 80218
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Denver, Colorado, United States, 80262
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St. Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606
Hospital of Saint Raphael
New Haven, Connecticut, United States, 06511
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
John F. Kennedy Medical Center
Atlantis, Florida, United States, 33462
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Halifax Medical Center
Daytona Beach, Florida, United States, 32114
North Ridge Medical Center
Fort Lauderdale, Florida, United States, 33334
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
Regional Medical Center Bayonet Point
Hudson, Florida, United States, 34667
Baptist Medical Center
Jacksonville, Florida, United States, 32207
Memorial Hospital
Jacksonville, Florida, United States, 32216
Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
Health First Holmes Regional Medical Center
Melbourne, Florida, United States, 32901
Orlando Regional Medical Center
Orlando, Florida, United States, 32801
Florida Hospital
Orlando, Florida, United States, 32803
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
Wuesthoff Hospital
Rockledge, Florida, United States, 32955
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Northside Hospital and Heart Institute
St. Petersburg, Florida, United States, 33701
University Community Hospital
Tampa, Florida, United States, 33613
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Emory University Hospital
Atlanta, Georgia, United States, 30322
Atlanta Veteran's Administration (VA) Medical Center
Decatur, Georgia, United States, 30033
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
St. Joseph's/Candler Health System
Savannah, Georgia, United States, 31404
St. Joseph's/Candler Health System
Savannah, Georgia, United States, 31419
United States, Hawaii
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
United States, Illinois
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Memorial Medical Center
Springfield, Illinois, United States, 62702
St. John's Hospital
Springfield, Illinois, United States, 62769
United States, Indiana
Indiana Ohio Heart
Fort Wayne, Indiana, United States, 46804
Clarian Health Partners, Inc. Methodist Hospital
Indianapolis, Indiana, United States, 46202
The Indiana Heart Hospital
Indianapolis, Indiana, United States, 46250
The Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
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Iowa Heart Center
Des Moines, Iowa, United States, 50314
United States, Kansas
Olathe Medical Center
Olathe, Kansas, United States, 66061
Galichia Heart Hospital
Wichita, Kansas, United States, 67202
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Central Baptist Hospital
Lexington, Kentucky, United States, 40503
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Lexington, Kentucky, United States, 40506
University of Kentucky
Lexington, Kentucky, United States, 40536
Jewish Hospital
Louisville, Kentucky, United States, 40202
Norton Hospital
Louisville, Kentucky, United States, 40202
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
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Terrebonne General Medical Center
Houma, Louisiana, United States, 70360
Louisiana Heart Hospital
LaCombe, Louisiana, United States, 70445
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112
Oschner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Pendleton Memorial Methodist Hospital
New Orleans, Louisiana, United States, 70127
Touro Infirmary
New Orleans, Louisiana, United States
Slidell Memorial Hospital
Slidell, Louisiana, United States, 70458
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Peninusla Medical Center
Salisbury, Maryland, United States, 21801
St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Veterans Administration (VA) Boston Healthcare System
West Roxbury, Massachusetts, United States, 02132
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
McLaren Regional Medical Center
Flint, Michigan, United States, 48532
Spectrum Health Hospitals
Grand Rapids, Michigan, United States, 49503
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
West Shore Cardiology Research Department
Muskegon, Michigan, United States, 46444
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Covenant Medical Center
Saginaw, Michigan, United States, 48601
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Mayo Clinic College of Medicine
Rochester, Minnesota, United States, 55905
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St. Luke's Health System
Kansas City, Missouri, United States, 64111
Saint Louis University Hospital
St. Louis, Missouri, United States, 63110
Saint Louis University
St. Louis, Missouri, United States, 63110
Des Peres Hospital
St. Louis, Missouri, United States, 63122
United States, Nebraska
Nebraska Heart Hospital
Lincoln, Nebraska, United States, 68506
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Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08035
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Camden, New Jersey, United States, 08103
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Camden, New Jersey, United States, 08103
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Hackensack, New Jersey, United States, 07601
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
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Montefiore Medical Center
Bronx, New York, United States, 10461
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Brooklyn, New York, United States, 11219
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Johnson City, New York, United States, 13790
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New York City, New York, United States, 10021
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New York City, New York, United States, 10029
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Poughkeepsie, New York, United States, 12601
Rochester General Hospital
Rochester, New York, United States, 14621
University of Rochester Medical Center
Rochester, New York, United States, 14642
Westchester Medical Center
Valhalla, New York, United States, 10595
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University of North Carolina at Chapel Hill Hospitals
Chapel Hill, North Carolina, United States, 27599-7075
Duke University Medical Center
Durham, North Carolina, United States, 27710
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27858
United States, North Dakota
Medcenter One
Bismarck, North Dakota, United States, 58501
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0542
University Hospitals Health System
Cleveland, Ohio, United States, 44106-5011
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
The Dayton Heart Hospital
Dayton, Ohio, United States, 45408
The Toledo Hospital
Toledo, Ohio, United States, 43606
Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
St. Charles Medical Center
Bend, Oregon, United States, 97701
Legacy Good Samaritan Hospital
Portland, Oregon, United States, 97210
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Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
St. Mary Medical Center
Langhorne, Pennsylvania, United States, 19067
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Crozer Chester Medical Center
Upland, Pennsylvania, United States, 19013
The Chester County Hospital
West Chester, Pennsylvania, United States, 19380
United States, South Carolina
Roper St. Francis Healthcare
Charleston, South Carolina, United States, 29401
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Tennessee
The Chattanooga Heart Institute
Chattanooga, Tennessee, United States, 37404
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
Baptist Hospital
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-8815
Methodist Medical Center
Oak Ridge, Tennessee, United States, 37830
United States, Texas
Heart Hospital of Austin
Austin, Texas, United States, 78756
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Christus Saint Joseph Hospital
Houston, Texas, United States, 77002
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030-4298
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital - Texas Heart
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
Covenant Medical Center
Lubbock, Texas, United States, 79410
TexSan Heart Hospital
San Antonio, Texas, United States, 78201
Northeast Baptist Hospital
San Antonio, Texas, United States, 78217
United States, Utah
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Hospital Center
Arlington, Virginia, United States, 22205
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Memorial Regional Medical Center
Mechanicsville, Virginia, United States, 23116
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
CJW Medical Center
Richmond, Virginia, United States, 23225
Henrico Doctors' Hospital
Richmond, Virginia, United States, 23229
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6310
Saint Joseph Medical Center
Tacoma, Washington, United States, 98405
United States, West Virginia
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Hopital Minjoz
Besancon, France, 25030
Hopital du Bocage
Dijon, France, 21031
Hopital Albert Michallon
Grenoble, France, 38043
Hopital Europeen Georges Pompidou
Paris, France, 75908
Zentrum fuer Herzchirurgie der Frederick-Alexander-Universitaet
Erlangen, Germany, 91054
Leiden University Medical Center
Leiden, Netherlands, 2333
Sponsors and Collaborators
Alexion Pharmaceuticals
Procter and Gamble
Study Director: Peter X Adams, MD Alexion Pharmaceuticals
Study Chair: Edward Verrier, MD University of Washington
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00088179     History of Changes
Other Study ID Numbers: 2003141
First Posted: July 23, 2004    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

Keywords provided by Alexion Pharmaceuticals:

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases