ClinicalTrials.gg
CompletedNCT00088179Updated Feb 22, 2018

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

A Phase 3 interventional study of pexelizumab in conjunction with CABG in Coronary Artery Disease, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 188 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-22.

Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
4,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • CABG
  • CPB
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's enrollment of 4,000 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 255 studies on the registry; 24 are open to participants now.

Of its 101 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

First submitted before Alexion Pharmaceuticals, Inc. became part of AstraZeneca.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
4,000 participants

Interventions

  • Drugpexelizumab in conjunction with CABG
06

What researchers measure

Primary outcomes

  1. Reduction in mortality.

  2. Reduction in MI incidence.

07

Study locations

188 sites
  • Brookwood Medical Center
    Birmingham, Alabama 35209, United States
  • Baptist Medical Center Princeton
    Birmingham, Alabama 35211, United States
  • Baptist Health Systems Montclair
    Birmingham, Alabama 35213, United States
  • Medical Center East Hospital
    Birmingham, Alabama 35235, United States
  • University of Alabama at Birmingham Hospital
    Birmingham, Alabama 35249-6810, United States
  • Thomas Hospital
    Fairhope, Alabama 36532, United States
  • Huntsville Hospital
    Huntsville, Alabama 35801, United States
  • Mobile Infirmary Medical Center
    Mobile, Alabama 36607, United States
  • Banner Good Samaritan Medical Center
    Phoenix, Arizona 85006, United States
  • Arizona Health Sciences Center
    Tucson, Arizona 85724, United States
  • University Medical Center
    Tucson, Arizona 85724, United States
  • Southern Arizona Veterans Affairs Health Care System
    Tucson, Arizona 85732, United States
  • Sparks Regional Medical Center
    Fort Smith, Arkansas 72901, United States
  • Baptist Medical Center
    Little Rock, Arkansas 72205, United States
  • Bakersfield Heart Hospital
    Bakersfield, California 93301, United States
  • Seaton Medical Center
    Daly City, California 94015, United States
  • Palomar Medical Center
    Escondido, California 92025, United States
  • Saddleback Memorial Medical Center
    Laguna Hills, California 92653, United States
  • Los Angeles County-University of Southern California Medical Center
    Los Angeles, California 90033, United States
  • University of Southern California University Hospital
    Los Angeles, California 90033, United States
  • St. Vincent Medical Center
    Los Angeles, California 90057, United States
  • Veterans Administration Greater Los Angeles Healthcare Sysytem
    Los Angeles, California 90073, United States
  • Tri City Medical Center
    Oceanside, California 92056, United States
  • University of California Irvine Medical Center
    Orange, California 92868, United States
  • Veterans Administration Palo Alto Healthcare System
    Palo Alto, California 94304, United States
  • Huntington Memorial Hospital
    Pasadena, California 91105, United States
  • Mercy General Hospital
    Sacramento, California 95819, United States
  • Sharp Memorial Hospital
    San Diego, California 92123, United States
  • Kaiser Permanente Medical Center
    San Francisco, California 94115, United States
  • Porter Adventist Hospital
    Denver, Colorado 80210, United States
  • Presbyterian St.Luke's Medical Center
    Denver, Colorado 80218, United States
  • University of Colorado Health Sciences Center
    Denver, Colorado 80262, United States
  • St. Vincent's Medical Center
    Bridgeport, Connecticut 06606, United States
  • Hospital of Saint Raphael
    New Haven, Connecticut 06511, United States
  • Christiana Hospital
    Newark, Delaware 19718, United States
  • John F. Kennedy Medical Center
    Atlantis, Florida 33462, United States
  • Morton Plant Hospital
    Clearwater, Florida 33756, United States
  • Halifax Medical Center
    Daytona Beach, Florida 32114, United States
  • North Ridge Medical Center
    Fort Lauderdale, Florida 33334, United States
  • Shands Hospital at the University of Florida
    Gainesville, Florida 32610, United States
  • Regional Medical Center Bayonet Point
    Hudson, Florida 34667, United States
  • Baptist Medical Center
    Jacksonville, Florida 32207, United States
  • Memorial Hospital
    Jacksonville, Florida 32216, United States
  • Lakeland Regional Medical Center
    Lakeland, Florida 33805, United States
  • Health First Holmes Regional Medical Center
    Melbourne, Florida 32901, United States
  • Orlando Regional Medical Center
    Orlando, Florida 32801, United States
  • Florida Hospital
    Orlando, Florida 32803, United States
  • Sacred Heart Hospital
    Pensacola, Florida 32504, United States
  • Wuesthoff Hospital
    Rockledge, Florida 32955, United States
  • Sarasota Memorial Hospital
    Sarasota, Florida 34239, United States
  • Northside Hospital and Heart Institute
    St. Petersburg, Florida 33701, United States
  • University Community Hospital
    Tampa, Florida 33613, United States
  • Piedmont Hospital
    Atlanta, Georgia 30309, United States
  • Emory University Hospital
    Atlanta, Georgia 30322, United States
  • Atlanta Veteran's Administration (VA) Medical Center
    Decatur, Georgia 30033, United States
  • Medical Center of Central Georgia
    Macon, Georgia 31208, United States
  • St. Joseph's/Candler Health System
    Savannah, Georgia 31404, United States
  • St. Joseph's/Candler Health System
    Savannah, Georgia 31419, United States
  • Kaiser Permanente Moanalua Medical Center
    Honolulu, Hawaii 96819, United States
  • OSF Saint Francis Medical Center
    Peoria, Illinois 61637, United States
  • Memorial Medical Center
    Springfield, Illinois 62702, United States
  • St. John's Hospital
    Springfield, Illinois 62769, United States
  • Indiana Ohio Heart
    Fort Wayne, Indiana 46804, United States
  • Clarian Health Partners, Inc. Methodist Hospital
    Indianapolis, Indiana 46202, United States
  • The Indiana Heart Hospital
    Indianapolis, Indiana 46250, United States
  • The Heart Center of Indiana
    Indianapolis, Indiana 46290, United States
  • Iowa Heart Center
    Des Moines, Iowa 50314, United States
  • Olathe Medical Center
    Olathe, Kansas 66061, United States
  • Galichia Heart Hospital
    Wichita, Kansas 67202, United States
  • Central Baptist Hospital
    Lexington, Kentucky 40503, United States
  • Veterans Affairs Medical Center
    Lexington, Kentucky 40506, United States
  • University of Kentucky
    Lexington, Kentucky 40536, United States
  • Jewish Hospital
    Louisville, Kentucky 40202, United States
  • Norton Hospital
    Louisville, Kentucky 40202, United States
  • University of Louisville Hospital
    Louisville, Kentucky 40202, United States
  • Terrebonne General Medical Center
    Houma, Louisiana 70360, United States
  • Louisiana Heart Hospital
    Lacombe, Louisiana 70445, United States
  • Tulane University Hospital and Clinic
    New Orleans, Louisiana 70112, United States
  • Oschner Clinic Foundation
    New Orleans, Louisiana 70121, United States
  • Pendleton Memorial Methodist Hospital
    New Orleans, Louisiana 70127, United States
  • Touro Infirmary
    New Orleans, Louisiana, United States
  • Slidell Memorial Hospital
    Slidell, Louisiana 70458, United States
  • Maine Medical Center
    Portland, Maine 04102, United States
  • Sinai Hospital of Baltimore
    Baltimore, Maryland 21215, United States
  • Union Memorial Hospital
    Baltimore, Maryland 21218, United States
  • Peninusla Medical Center
    Salisbury, Maryland 21801, United States
  • St. Joseph Medical Center
    Towson, Maryland 21204, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Cape Cod Hospital
    Hyannis, Massachusetts 02601, United States
  • Baystate Medical Center
    Springfield, Massachusetts 01199, United States
  • Veterans Administration (VA) Boston Healthcare System
    West Roxbury, Massachusetts 02132, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • McLaren Regional Medical Center
    Flint, Michigan 48532, United States
  • Spectrum Health Hospitals
    Grand Rapids, Michigan 49503, United States
  • Borgess Medical Center
    Kalamazoo, Michigan 49048, United States
  • Ingham Regional Medical Center
    Lansing, Michigan 48910, United States
  • West Shore Cardiology Research Department
    Muskegon, Michigan 46444, United States
  • William Beaumont Hospital
    Royal Oak, Michigan 48073, United States
  • Covenant Medical Center
    Saginaw, Michigan 48601, United States

Showing the first 100 of 188 sites across 4 countries.

08

References and documents

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. PubMed 20880552 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00088179
Collaborators
Procter and Gamble
First posted
Jul 23, 2004
Start date
Jul 2004
Primary completion
Oct 2005
Completion
Oct 2005
Last update
Feb 22, 2018

Study contacts

Peter X Adams, MD
study director · Alexion Pharmaceuticals, Inc.
Edward Verrier, MD
study chair · University of Washington
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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