Schering-Plough initiates enrollment in Phase III study of heart drug

Schering-Plough has initiated patient enrollment in RED-CABG, the Phase III trial for acadesine, an investigational adenosine regulating agent.

Acadesine was licensed from PeriCor Therapeutics, a specialty biopharmaceutical company. Acadesine is being studied as intravenous infusion for the prevention of ischemia-reperfusion injury, a complication of cardiac surgery in patients undergoing coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass.

The RED-CABG (reduction in cardiovascular events by acadesine in subjects undergoing CABG) trial is a randomized, double-blind, placebo-controlled, multinational, Phase III study of 7,500 high-risk patients undergoing on-pump CABG. High-risk patients are defined as either female, 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.

Enrico Veltri, group vice president of global clinical research, cardiovascular and metabolic diseases at Schering-Plough Research Institute, said: We are pleased to be initiating the RED-CABG Phase III clinical trial for acadesine, which has the potential to reduce perioperative complications in patients undergoing CABG surgery. Schering-Plough is committed to addressing the significant unmet medical need in ischemia-reperfusion injury in this patient population.