Review Article
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.
|