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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Alexion Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00088179
First received: July 21, 2004
Last updated: August 28, 2005
Last verified: August 2005
  Purpose

During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine.


Condition Intervention Phase
Coronary Artery Disease
Drug: pexelizumab in conjunction with CABG
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)

Resource links provided by NLM:


Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • Reduction in mortality.
  • Reduction in MI incidence.

Estimated Enrollment: 4000
Study Start Date: July 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088179

  Show 188 Study Locations
Sponsors and Collaborators
Alexion Pharmaceuticals
Procter and Gamble
Investigators
Study Director: Peter X Adams, MD Alexion Pharmaceuticals
Study Chair: Edward Verrier, MD University of Washington
  More Information

No publications provided by Alexion Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00088179     History of Changes
Other Study ID Numbers: 2003141
Study First Received: July 21, 2004
Last Updated: August 28, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexion Pharmaceuticals:
CABG
CPB

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

ClinicalTrials.gov processed this record on October 23, 2014