Apixaban: Interim Phase III data

The double-blind, international Phase III AVERROES trial in 5,600 patients was stopped early after an interim analysis by an independent DMC showed that apixaban led to a "clinically important" reduction on the primary endpoint of time to first occurrence of stroke and systemic embolism vs. aspirin. The analysis also showed that apixaban demonstrated an acceptable safety profile compared to aspirin. The trial enrolled patients with AF at risk for stroke who were considered intolerant of or unsuitable for therapy with a vitamin K antagonist such as warfarin. Patients received 5 mg twice-daily apixaban or 81-324 mg daily aspirin. ...