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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pexelizumab in conjunction with CABG
Sponsored by
Alexion
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, CPB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brookwood Medical Center
  • Baptist Medical Center Princeton
  • Baptist Health Systems Montclair
  • Medical Center East Hospital
  • University of Alabama at Birmingham Hospital
  • Thomas Hospital
  • Huntsville Hospital
  • Mobile Infirmary Medical Center
  • Banner Good Samaritan Medical Center
  • Arizona Health Sciences Center
  • University Medical Center
  • Southern Arizona Veterans Affairs Health Care System
  • Sparks Regional Medical Center
  • Baptist Medical Center
  • Bakersfield Heart Hospital
  • Seaton Medical Center
  • Palomar Medical Center
  • Saddleback Memorial Medical Center
  • Los Angeles County-University of Southern California Medical Center
  • University of Southern California University Hospital
  • St. Vincent Medical Center
  • Veterans Administration Greater Los Angeles Healthcare Sysytem
  • Tri City Medical Center
  • University of California Irvine Medical Center
  • Veterans Administration Palo Alto Healthcare System
  • Huntington Memorial Hospital
  • Mercy General Hospital
  • Sharp Memorial Hospital
  • Kaiser Permanente Medical Center
  • Porter Adventist Hospital
  • Presbyterian St.Luke's Medical Center
  • University of Colorado Health Sciences Center
  • St. Vincent's Medical Center
  • Hospital of Saint Raphael
  • Christiana Hospital
  • John F. Kennedy Medical Center
  • Morton Plant Hospital
  • Halifax Medical Center
  • North Ridge Medical Center
  • Shands Hospital at the University of Florida
  • Regional Medical Center Bayonet Point
  • Baptist Medical Center
  • Memorial Hospital
  • Lakeland Regional Medical Center
  • Health First Holmes Regional Medical Center
  • Orlando Regional Medical Center
  • Florida Hospital
  • Sacred Heart Hospital
  • Wuesthoff Hospital
  • Northside Hospital and Heart Institute
  • Sarasota Memorial Hospital
  • University Community Hospital
  • Piedmont Hospital
  • Emory University Hospital
  • Atlanta Veteran's Administration (VA) Medical Center
  • Medical Center of Central Georgia
  • St. Joseph's/Candler Health System
  • St. Joseph's/Candler Health System
  • Kaiser Permanente Moanalua Medical Center
  • OSF Saint Francis Medical Center
  • Memorial Medical Center
  • St. John's Hospital
  • Indiana Ohio Heart
  • Clarian Health Partners, Inc. Methodist Hospital
  • The Indiana Heart Hospital
  • The Heart Center of Indiana
  • Iowa Heart Center
  • Olathe Medical Center
  • Galichia Heart Hospital
  • Central Baptist Hospital
  • Veterans Affairs Medical Center
  • University of Kentucky
  • Jewish Hospital
  • Norton Hospital
  • University of Louisville Hospital
  • Terrebonne General Medical Center
  • Louisiana Heart Hospital
  • Tulane University Hospital and Clinic
  • Oschner Clinic Foundation
  • Pendleton Memorial Methodist Hospital
  • Touro Infirmary
  • Slidell Memorial Hospital
  • Maine Medical Center
  • Sinai Hospital of Baltimore
  • Union Memorial Hospital
  • Peninusla Medical Center
  • St. Joseph Medical Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Cape Cod Hospital
  • Baystate Medical Center
  • Veterans Administration (VA) Boston Healthcare System
  • Henry Ford Health System
  • McLaren Regional Medical Center
  • Spectrum Health Hospitals
  • Borgess Medical Center
  • Ingham Regional Medical Center
  • West Shore Cardiology Research Department
  • William Beaumont Hospital
  • Covenant Medical Center
  • Mayo Clinic College of Medicine
  • St. Luke's Health System
  • Saint Louis University Hospital
  • Saint Louis University
  • Des Peres Hospital
  • Nebraska Heart Hospital
  • Cooper Hospital University Medical Center
  • Cooper Health System/University Medical Center
  • Our Lady Of Lourdes Medical Center
  • Hackensack University Medical Center
  • Morristown Memorial Hospital
  • Montefiore Medical Center
  • Maimondes Medical Center
  • United Health Services Hospital
  • New York Presbyterian Hospital
  • Mount Sinai Hospital
  • Vassar Brothers Medical Center
  • Rochester General Hospital
  • University of Rochester Medical Center
  • Westchester Medical Center
  • University of North Carolina at Chapel Hill Hospitals
  • Duke University Medical Center
  • Moses H. Cone Memorial Hospital
  • Pitt County Memorial Hospital
  • Medcenter One
  • Akron General Medical Center
  • The Christ Hospital
  • Good Samaritan Hospital
  • Bethesda North Hospital
  • University of Cincinnati Medical Center
  • University Hospitals Health System
  • The Cleveland Clinic Foundation
  • Riverside Methodist Hospital
  • The Dayton Heart Hospital
  • The Toledo Hospital
  • Good Samaritan Hospital
  • Oklahoma University Medical Center
  • INTEGRIS Baptist Medical Center
  • Oklahoma Heart Hospital
  • St. Charles Medical Center
  • Legacy Good Samaritan Hospital
  • Doylestown Hospital
  • St. Mary Medical Center
  • Hahnemann University Hospital
  • Presbyterian Medical Center
  • Temple University Hospital
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • Crozer Chester Medical Center
  • The Chester County Hospital
  • Roper St. Francis Healthcare
  • Rapid City Regional Hospital
  • The Chattanooga Heart Institute
  • Jackson-Madison County General Hospital
  • Baptist Memorial Hospital
  • Baptist Hospital
  • Vanderbilt University Medical Center
  • Methodist Medical Center
  • Heart Hospital of Austin
  • Medical City Dallas Hospital
  • Christus Saint Joseph Hospital
  • Michael E. DeBakey Veterans Affairs Medical Center
  • Memorial Hermann Hospital
  • Methodist Hospital
  • St. Luke's Episcopal Hospital - Texas Heart
  • The Methodist Hospital
  • Covenant Medical Center
  • TexSan Heart Hospital
  • Northeast Baptist Hospital
  • University of Utah Hospital
  • Virginia Hospital Center
  • University of Virginia Health System
  • Inova Fairfax Hospital
  • Memorial Regional Medical Center
  • Sentara Norfolk General Hospital
  • CJW Medical Center
  • Henrico Doctors' Hospital
  • University of Washington Medical Center
  • Saint Joseph Medical Center
  • Charleston Area Medical Center
  • Gundersen Lutheran Medical Center
  • St. Luke's Medical Center
  • Hopital Minjoz
  • Hopital du Bocage
  • Hopital Albert Michallon
  • Hopital Europeen Georges Pompidou
  • Zentrum fuer Herzchirurgie der Frederick-Alexander-Universitaet
  • Leiden University Medical Center

Outcomes

Primary Outcome Measures

Reduction in mortality.
Reduction in MI incidence.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2004
Last Updated
February 20, 2018
Sponsor
Alexion
Collaborators
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT00088179
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2004 (Actual)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alexion
Collaborators
Procter and Gamble

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CABG, CPB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
4000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pexelizumab in conjunction with CABG
Primary Outcome Measure Information:
Title
Reduction in mortality.
Title
Reduction in MI incidence.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
20880552
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.
Results Reference
derived

Learn more about this trial

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

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