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The design of ROCKET AF is shown in this Figure.[97][115] ROCKET AF enrolled patients with nonvalvular AFib at moderate-to-high risk of stroke, with the following CHADS2 risk factors: the patients had to have prior stroke, transient ischemic attack (TIA), or non-CNS embolus, or at least 2 other CHADS2 risk factors. If subjects had only 2 risk factors, but no prior stroke, TIA, or embolism, they were excluded -- in other words, the ROCKET AF population had a high CHADS2 risk score.
Subjects were then randomized to rivaroxaban (20 mg/day or 15 mg/day for patients with CrCl 30–50 mL/min) or warfarin, in a double-blind, double-dummy fashion for the patients and the physicians in the trial, with adjudication of results also double-blind. The primary efficacy endpoint was the composite of stroke and non-CNS embolism, and the primary safety endpoint was a composite of major and non-major (but clinically relevant) bleeding.
Reiffel JA. Am J Med 2013; 126: 00-00.
[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.
[115] ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010;159:340-347.