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The Figure illustrates the flow diagram for the ARISTOTLE trial with apixaban versus INR-adjusted warfarin.[99] It can be seen that both the inclusion and exclusion factors were very similar to those in the RE-LY trial with dabigatran.[96] On the other hand, unlike RE-LY, ARISTOTLE was double-blind, double-dummy trial, the same as ROCKET AF with rivaroxaban.[[97] Based on dose-ranging studies, the dose of apixaban was set at 5 mg twice a day (bid, as with dabigatran). In selected patients, based on age, body weight, and renal function (serum creatine ≥1.5 mg/dL), the dose might be halved to 2.5 mg bid. The primary outcome and safety outcomes were exactly the same as in the trials with dabigatran and rivaroxaban.
Reiffel JA. Am J Med 2013; 126: 00-00.
[96] Connolly SJ, Ezekowitz MD, Yusuf S, et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-1151.
[97] Patel MR, Mahaffey KW, Garg J, et al; the ROCKET AF Steering Committee, for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-891.
[99] Granger CB, Alexander JH, McMurray JV, et al; the ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981-992.