Skip to main content
. Author manuscript; available in PMC: 2015 May 1.
Published in final edited form as: Curr Opin Nephrol Hypertens. 2014 May;23(3):275–282. doi: 10.1097/01.mnh.0000444820.80249.56

Table 2.

Overview of phase III randomized trials of new oral anticoagulants

Study (n) Agents Design features Exclusion criteria related to CKD Dose adjustment related to CKD Stage 3 CKD (%) Mean time in therapeutic range (INR 2– 3) Main results
RE-LY68 Dabigat ran 150 mg or 110 mg twice daily vs. warfarin Warfarin given open- label eCrCl<30 ml/min None 10% eCrCl 30–49 ml/min 64% Stroke, non-CNS embolism and cardiovascular mortality reduced by dabigatran 150 mg vs. warfarin; major haemorrhage reduced by dabigatran 110 mg vs. warfarin; intracranial bleeding reduced by both doses of dabigatran vs. warfarin; no significant differences in total mortality
AVERROES67 (5,599) Apixaban 5 mg twice daily vs. aspirin Double- blind; restricted to those deemed unsuitable for warfarin Serum creatinine >221 umol/L or eCrCr<25 ml/min 2.5 mg twice daily if serum creatinine ≥ 133 umol/L plus age ≥ 80 years or weight ≤60 kg 30% eCrCl 30–59 ml/min NA Stroke and non-CNS embolism reduced by apixaban vs aspirin; major haemorrhage and intracranial bleeding comparable with both agents; no significant difference in cardiovascular or total mortality
ROCKET AF69 (14, 264) Rivaroxaban 20 mg per day vs. warfarin Double- blind; restricted to those at high risk of stroke eCrCl<30 ml/min 15 mg per day if CrCl<50 ml/min 21% eCrCl 30–49 ml/min 55% Rivaroxaban noninferior to warfarin for stroke and non-CNS embolism; major haemorrhage comparable with both agents; intracranial bleeding reduced by rivaroxaban vs. warfarin; no significant difference in cardiovascular or total mortality
ARISTOTLE55 Apixaban 5 mg twice daily vs. warfarin Double- blind Serum creatinine >221 umol/L or eCrCl<25 ml/min 2.5 mg twice daily if serum creatinine ≥ 133 umol/L plus age ≥ 80 years or weight ≤ 60 kg 15% eCrCl 30–50 ml/min 62% Stroke, non-CNS embolism, major haemorrhage, intracranial bleeding and total mortality reduced by apixaban vs. warfarin; no significant difference in cardiovascular mortality

Abbreviations: CKD=chronic kidney disease; CNS=central nervous system; eCrCl=estimated creatinine clearance; INR=international normalized ratio; NA=not available

Hart, R. G. (2012) Anticoagulants in atrial fibrillation patients with chronic kidney disease et al. Nat. Rev. Nephrol. doi:10.1038/nrneph.2012.160