ARISTOTLE

ARISTOTLE was a randomised, double-blind trial completed in 2011, comparing apixaban with warfarin in the prevention of stroke and SE. The trial included 18 201 patients with AF and at least one additional risk factor for stroke. The trial was designed to test for non-inferiority of apixaban compared with warfarin, and showed apixaban superiority for (1) the primary outcome of stroke or SE (HR 0.79, 95% CI 0.66 to 0.95),⁷ (2) the safety endpoint of major bleeding (HR 0.69, 95% CI 0.60 to 0.80), and (3) death from any cause (HR 0.89, 95% CI 0.80 to 0.99). The ARISTOTLE findings led to the National Institute for Health and Care Excellence (NICE) guidelines on stroke prophylaxis in patients with AF recommending apixaban as a treatment. Baseline patient characteristics from ARISTOTLE will be used in selection of participants in Objective 1.