Apixaban: Phase III discontinued

Bristol-Myers and Pfizer discontinued the double-blind, placebo-controlled, international Phase III APPRAISE-2 trial for ACS after the partners observed clear evidence of a clinically important increase in bleeding among patients receiving twice-daily 5 mg apixaban plus mono or dual antiplatelet therapy. Furthermore, the increase in bleeding was not offset by clinically meaningful reductions in ischemic events. The trial was designed to enroll about 10,800 patients. Additionally, the independent DMC for the Phase II APPRAISE Japan trial of apixaban in ACS patients has recommended the Japanese trial also be discontinued. Bristol-Myers said ongoing studies investigating apixaban in other patient populations will continue. ...