Clinical trial NCT00088179: Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: CABG
CPB
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2004-07-23
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in mortality.
measure: Reduction in MI incidence.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Brookwood Medical Center
state: Alabama
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Birmingham
country: United States
facility: Baptist Health Systems Montclair
state: Alabama
city: Birmingham
country: United States
facility: Medical Center East Hospital
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Hospital
state: Alabama
city: Fairhope
country: United States
facility: Thomas Hospital
state: Alabama
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: Mobile
country: United States
facility: Mobile Infirmary Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Tucson
country: United States
facility: Arizona Health Sciences Center
state: Arizona
city: Tucson
country: United States
facility: University Medical Center
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona Veterans Affairs Health Care System
state: Arizona
city: Fort Smith
country: United States
facility: Sparks Regional Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Baptist Medical Center
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Heart Hospital
state: California
city: Daly City
country: United States
facility: Seaton Medical Center
state: California
city: Escondido
country: United States
facility: Palomar Medical Center
state: California
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: Los Angeles County-University of Southern California Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California University Hospital
state: California
city: Los Angeles
country: United States
facility: St. Vincent Medical Center
state: California
city: Los Angeles
country: United States
facility: Veterans Administration Greater Los Angeles Healthcare Sysytem
state: California
city: Oceanside
country: United States
facility: Tri City Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Palo Alto
country: United States
facility: Veterans Administration Palo Alto Healthcare System
state: California
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Denver
country: United States
facility: Porter Adventist Hospital
state: Colorado
city: Denver
country: United States
facility: Presbyterian St.Luke's Medical Center
state: Colorado
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Bridgeport
country: United States
facility: St. Vincent's Medical Center
state: Connecticut
city: New Haven
country: United States
facility: Hospital of Saint Raphael
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Atlantis
country: United States
facility: John F. Kennedy Medical Center
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Daytona Beach
country: United States
facility: Halifax Medical Center
state: Florida
city: Fort Lauderdale
country: United States
facility: North Ridge Medical Center
state: Florida
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
city: Hudson
country: United States
facility: Regional Medical Center Bayonet Point
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Melbourne
country: United States
facility: Health First Holmes Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Rockledge
country: United States
facility: Wuesthoff Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital and Heart Institute
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: University Community Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Decatur
country: United States
facility: Atlanta Veteran's Administration (VA) Medical Center
state: Georgia
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Savannah
country: United States
facility: St. Joseph's/Candler Health System
state: Georgia
city: Savannah
country: United States
facility: St. Joseph's/Candler Health System
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center
state: Hawaii
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Indiana Ohio Heart
state: Indiana
city: Indianapolis
country: United States
facility: Clarian Health Partners, Inc. Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: The Indiana Heart Hospital
state: Indiana
city: Indianapolis
country: United States
facility: The Heart Center of Indiana
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Olathe
country: United States
facility: Olathe Medical Center
state: Kansas
city: Wichita
country: United States
facility: Galichia Heart Hospital
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Lexington
country: United States
facility: Veterans Affairs Medical Center
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Houma
country: United States
facility: Terrebonne General Medical Center
state: Louisiana
city: Lacombe
country: United States
facility: Louisiana Heart Hospital
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Hospital and Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Oschner Clinic Foundation
state: Louisiana
city: New Orleans
country: United States
facility: Pendleton Memorial Methodist Hospital
state: Louisiana
city: New Orleans
country: United States
facility: Touro Infirmary
state: Louisiana
city: Slidell
country: United States
facility: Slidell Memorial Hospital
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Salisbury
country: United States
facility: Peninusla Medical Center
state: Maryland
city: Towson
country: United States
facility: St. Joseph Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: West Roxbury
country: United States
facility: Veterans Administration (VA) Boston Healthcare System
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Flint
country: United States
facility: McLaren Regional Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Lansing
country: United States
facility: Ingham Regional Medical Center
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: Rochester
country: United States
facility: Mayo Clinic College of Medicine
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Health System
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Des Peres Hospital
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Hospital
state: Nebraska
city: Camden
country: United States
facility: Cooper Hospital University Medical Center
state: New Jersey
city: Camden
country: United States
facility: Cooper Health System/University Medical Center
state: New Jersey
city: Camden
country: United States
facility: Our Lady Of Lourdes Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Maimondes Medical Center
state: New York
city: Johnson City
country: United States
facility: United Health Services Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill Hospitals
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Greenville
country: United States
facility: Pitt County Memorial Hospital
state: North Carolina
city: Bismarck
country: United States
facility: Medcenter One
state: North Dakota
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Health System
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Dayton
country: United States
facility: The Dayton Heart Hospital
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Zanesville
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Bend
country: United States
facility: St. Charles Medical Center
state: Oregon
city: Portland
country: United States
facility: Legacy Good Samaritan Hospital
state: Oregon
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
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: Upland
country: United States
facility: Crozer Chester Medical Center
state: Pennsylvania
city: West Chester
country: United States
facility: The Chester County Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Roper St. Francis Healthcare
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Chattanooga
country: United States
facility: The Chattanooga Heart Institute
state: Tennessee
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Baptist Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Oak Ridge
country: United States
facility: Methodist Medical Center
state: Tennessee
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Houston
country: United States
facility: Christus Saint Joseph Hospital
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey Veterans Affairs Medical Center
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital - Texas Heart
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Lubbock
country: United States
facility: Covenant Medical Center
state: Texas
city: San Antonio
country: United States
facility: TexSan Heart Hospital
state: Texas
city: San Antonio
country: United States
facility: Northeast Baptist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Arlington
country: United States
facility: Virginia Hospital Center
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Mechanicsville
country: United States
facility: Memorial Regional Medical Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: CJW Medical Center
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors' Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Tacoma
country: United States
facility: Saint Joseph Medical Center
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Besancon
country: France
facility: Hopital Minjoz
city: Dijon
country: France
facility: Hopital du Bocage
city: Grenoble
country: France
facility: Hopital Albert Michallon
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Erlangen
country: Germany
facility: Zentrum fuer Herzchirurgie der Frederick-Alexander-Universitaet
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Alexion Pharmaceuticals, Inc.
name: Peter X Adams, MD
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Edward Verrier, MD
role: STUDY_CHAIR
References:
citation: 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.