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Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00048308
First Posted: October 31, 2002
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alexion Pharmaceuticals
  Purpose
During a heart bypass procedure, a substance called "complement" is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, heart failure, or impairment of memory, language and motor skills. The purpose of this study is to find out if the study drug (pexelizumab), which blocks complement release, can reduce such side effects and be taken safely.

Condition Intervention Phase
Cardio-pulmonary Bypass Coronary Artery Bypass Graft Drug: pexelizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Alexion Pharmaceuticals:

Estimated Enrollment: 3000
Actual Study Start Date: January 2002
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

The study population will be drawn from patients undergoing CABG or CABG plus valve surgery using a bypass pump. In addition, they must meet all of the following criteria:

  • be at least 18 years of age;
  • have one or more of the following risk factors:
  • diabetes mellitus;
  • prior CABG;
  • the need for urgent intervention, defined according to the American College of Cardiology/ American Heart Association (ACC/AHA) guidelines as being patients who are required to stay in the hospital, but may be scheduled and operated on within a normal scheduling routine, excluding patients who have had a 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 (New York Heart Association [NYHA]Class III or IV);
  • history of 2 myocardial infarctions, or a myocardial infarction that occurred greater than 48 hours but less than four (4) weeks prior to CABG;
  • provide Informed Consent.

EXCLUSION CRITERIA:

A patient will be ineligible for study entry if he/she meets any of the following exclusion criteria:

  • has planned aortic dissection repair and/or requires aortic root reconstruction;
  • requires salvage intervention as defined by the ACC/AHA guidelines 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 uncontrolled diabetes, defined as a documented plasma blood glucose value > 400 mg/dl (22.2 mmol/L) within three (3) days before surgery;
  • has a history of renal failure and a serum creatinine value greater than 3.0 mg/dl;
  • has a history of chronic hepatic failure and/or hepatic cirrhosis;
  • has a history of malignancy, excepting basal cell carcinoma and malignancies in remission (greater than 2 years);
  • 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 any serious medical condition which, in the opinion of the investigator is likely to alter the patient's course of recovery or the evaluation of the study medication's safety;
  • has a history of alcohol or drug abuse within the past year;
  • 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 during the trial;
  • is pregnant or breast-feeding.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048308


  Show 186 Study Locations
Sponsors and Collaborators
Alexion Pharmaceuticals
  More Information

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00048308     History of Changes
Other Study ID Numbers: 2000099
PRIMO-CABG
First Submitted: October 29, 2002
First Posted: October 31, 2002
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Alexion Pharmaceuticals:
CABG