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

Completed · Phase 3

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00088179

Run by

Alexion Pharmaceuticals, Inc.

People needed

4000

Starts

2004-07-01

Expected to finish

2005-10-01

Last updated by the study team

2018-02-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baptist Medical Center Princeton — Birmingham, Alabama, United States
• Baptist Health Systems Montclair — Birmingham, Alabama, United States
• Medical Center East Hospital — Birmingham, Alabama, United States
• University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States
• Thomas Hospital — Fairhope, Alabama, United States
• Huntsville Hospital — Huntsville, Alabama, United States
• Mobile Infirmary Medical Center — Mobile, Alabama, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• Arizona Health Sciences Center — Tucson, Arizona, United States
• University Medical Center — Tucson, Arizona, United States
• Southern Arizona Veterans Affairs Health Care System — Tucson, Arizona, United States
• Sparks Regional Medical Center — Fort Smith, Arkansas, United States
• Baptist Medical Center — Little Rock, Arkansas, United States
• Bakersfield Heart Hospital — Bakersfield, California, United States
• Seaton Medical Center — Daly City, California, United States
• Palomar Medical Center — Escondido, California, United States
• Saddleback Memorial Medical Center — Laguna Hills, California, United States
• Los Angeles County-University of Southern California Medical Center — Los Angeles, California, United States
• University of Southern California University Hospital — Los Angeles, California, United States
• St. Vincent Medical Center — Los Angeles, California, United States
• Veterans Administration Greater Los Angeles Healthcare Sysytem — Los Angeles, California, United States
• Tri City Medical Center — Oceanside, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Veterans Administration Palo Alto Healthcare System — Palo Alto, California, United States
• Brookwood Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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