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)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: pexelizumab in conjunction with CABG

• Study Type: Interventional
• Enrollment: 4000
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction in mortality.
Reduction in MI incidence.

Collaborators and Investigators

• Sponsor: Alexion Pharmaceuticals
• Collaborators: Procter and Gamble
• Investigators: Study Director: Peter X Adams, MD, Alexion Pharmaceuticals; Study Chair: Edward Verrier, MD, University of Washington

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2004
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: July 21, 2004
• First Submitted That Met QC Criteria: July 22, 2004
• First Posted (Estimate): July 23, 2004

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: CABG; CPB
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2003141

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No