Bristol-Myers Squibb (BMS) and Pfizer are stopping the Phase 3 AVERROES clinical trial of apixaban in patients with atrial fibrillation. The study will be stopped early because a predefined interim analysis by the independent Data Monitoring Committee revealed evidence of a clinically important reduction in stroke and systemic embolism in patients with atrial fibrillation considered intolerant of or unsuitable for vitamin K antagonist therapy who received apixaban as compared to aspirin.
This interim analysis also demonstrated an acceptable safety profile for apixaban compared to aspirin, according to the New York City-headquartered companies.
The AVERROES (Apixaban Versus Acetylsalicylic Acid to Prevent Strokes) study included 5,600 patients with atrial fibrillation at risk for stroke who were considered intolerant of or unsuitable for therapy with a vitamin K antagonist such as warfarin (Coumadin, BMS). The researchers randomized patients to receive either apixaban 5 mg twice daily or aspirin 81 mg to 324 mg once daily.
Conducted in 36 countries, the study was coordinated by the Population Health Research Institute (PHRI) at McMaster University and at Hamilton Health Sciences in Hamilton, Ontario.
The AVERROES investigators have been informed of the decision to stop the study, reported BMS and Pfizer, adding they are working “to close out the study” and ensure that patients are informed of the opportunity to start treatment with apixaban in an open-label extension.
According to the companies, PHRI will complete an evaluation of the final AVERROES dataset and will seek to publish the results and present the findings at a scientific congress once the analysis is complete.
Apixaban is being investigated within the EXPANSE trials program, which is projected to include nearly 60,000 patients globally across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind phase 3 trials, including AVERROES.