Phase 3 study of Acadesine for ischemia-reperfusion injury

Schering-Plough Corporation announced the start of patient enrollment in their Phase 3 trial (RED-CABG) for acadesine to prevent ischemia-reperfusion injury, a complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass.

RED-CABG (Reduction in cardiovascular Events by acaDesine in subjects undergoing CABG) is a randomized, double-blind, placebo-controlled, multinational study of 7500 high-risk patients undergoing on-pump CABG. High-risk patients are defined as either females, or males with a previous history of CABG surgery, heart attack, stroke, low left ventricular ejection fraction, or diabetes mellitus. Patients will be randomized to either acadesine or placebo IV infusion started before anesthesia and continued for a total of seven hours through surgery and postoperatively. The primary endpoint is a composite of all-cause death, severe left ventricular dysfunction requiring mechanical support, or stroke at post-operative day 28. All-cause death will also be assessed at six months.

Acadesine is an investigational adenosine regulating agent (ARA).

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