Stroke Prevention in Atrial Fibrillation: Understanding the New Oral Anticoagulants Dabigatran, Rivaroxaban, and Apixaban

Table 2

RE-LY, ROCKET AF, and ARISTOTLE trial design and conduct.

	RE-LY [13]	ROCKET AF [14]	ARISTOTLE [15]
Patient number	18,113	14,264	18,201
Median followup, years	2.0	1.9	1.8
Trial design	PROBE*	Double blind	Double blind
Study drug	Dabigatran	Rivaroxaban	Apixaban
Study drug dose(s)	110 mg or 150 mg BD	20 mg OD	5 mg BD
Renal dose	None	15 mg OD	2.5 mg BD
Comparator	Open-label warfarin	Warfarin	Warfarin
Primary objective	Noninferior efficacy	Non-inferior efficacy	Non-inferior efficacy
Noninferiority margin(s)	1.46	1.46	1.44; 1.38 (log scale)
Primary efficacy analysis	Intention-to-treat	On treatment	Intention-to-treat

*PROBE: prospective open-label blinded endpoint evaluation; BD: twice daily; OD: once daily.