Clinical Trials

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of 2 mg/kg Bolus Plus 24-hour 0.05 mg/kg/hr Infusion of Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting with Cardiopulmonary Bypass (PRIMO-CABG II)

During a heart bypass procedure, a substance called “complement”, which is a substance normally produced by the body in response to tissue injury, is released. This substance causes inflammation, which can lead to side effects such as chest pain, heart attacks, and/or heart failure. The purpose of this study is to determine whether the study drug, Pexelizumab, which is investigational, can block the release of “complement” and in so doing:

1. reduce the above mentioned side effects
2. increase your chances of survival, and
3. decrease your chances of a heart attack during and after surgery.

Eligibility for enrollment:

1. Patients undergoing CABG or CABG plus valve surgery using a bypass pump
2. At least 18 years of age
3. Provide informed consent

At least 2 of the following risk factors are also required:

• Diabetes
• Repeat CABG
• The need for urgent surgery
• History of CVA, TIA or carotid endarterectomy
• History of congestive heart failure NYHA Functional Class III or IV
• History of 2 or more heart attacks

Primary Investigator: Vaughn A. Starnes, MD

Co-Investigators: Mark J. Cunningham, MD, Steven Haddy, MD

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