ARTICLE | Clinical News

Bristol-Myers, Pfizer discontinue apixaban trial

November 19, 2010 2:00 AM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) said they discontinued the Phase III APPRAISE-2 trial of apixaban for acute coronary syndrome (ACS) after the partners observed clear evidence of a clinically important increase in bleeding among patients receiving the direct Factor Xa inhibitor vs. placebo. 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. ...