A study of a new drug for atrial fibrillation, apixaban (Pfizer/Bristol-Myers Squibb), has been stopped early because of benefit.
The trial was stopped after a predefined interim analysis by the independent data monitoring committee “revealed clear evidence of a clinically important reduction in stroke and systemic embolism”, a company statement announced.
The AVERROES (Apixaban Versus Acetylsalicylic Acid to Prevent Strokes) study included 5,600 patients with all types of atrial fibrillation who were intolerant of or unsuitable for warfarin. They were randomised to 5 mg of apixaban or 81–324 mg of aspirin for up to 36 months.
The primary efficacy outcome is the time from the first dose of the study drug to the first occurrence of ischaemic stroke, haemorrhagic stroke, or systemic embolism. The secondary efficacy outcome includes the time to the first occurrence of ischaemic stroke, haemorrhagic stroke, systemic embolism, myocardial infarction, or vascular death.
Full results from the AVERROES study will be presented at the European Society of Cardiology 2010 Congress in Stockholm, Sweden.