Apixaban in acute coronary syndrome: APPRAISE-2 trial discontinued


Bristol-Myers Squibb and Pfizer have discontinued the Phase 3 APPRAISE-2 clinical trial in patients with recent acute coronary syndrome ( ACS ) treated with Apixaban or placebo in addition to mono or dual antiplatelet therapy.
The study was stopped early based on the recommendation of an independent Data Monitoring Committee ( DMC ). There was clear evidence of a clinically important increase in bleeding among patients randomized to Apixaban. This increase in bleeding was not offset by clinically meaningful reductions in ischemic events.

The APPRAISE-2 Trial ( Apixaban for Prevention of Acute Ischemic Events 2 ), one of nine clinical trials evaluating Apixaban in patients at risk of ischemic events, was designed to include approximately 10,800 patients with a recent acute coronary syndrome.
Patients were randomized to Apixaban 5 mg twice daily or placebo.
The study was conducted in 40 countries.

The recommendation to discontinue APPRAISE-2 concerns only the population of high-risk ACS patients receiving anti-platelet therapy enrolled in APPRAISE-2.

Apixaban is an investigational oral factor Xa inhibitor.

Source: Bristol-Myers Squibb, 2010

XagenaMedicine2010

Link: Xapedia - Medical Encyclopedia