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. Author manuscript; available in PMC: 2020 Feb 10.
Published in final edited form as: Ann N Y Acad Sci. 2015 Mar;1338:1–15. doi: 10.1111/nyas.12723

Table 3.

Summary of recent clinical trials on novel oral anticoagulants

Atrial fibrillation Drug Comparison Primary end point: stroke and systemic embolism ICH rate (% per year) Major bleeding event (% per year)
RE-LY14 Dabigatran 150 mg BID or 110mg BID Dose-adjusted warfarin 1.71% warfarin 1.54% dabigatran 110mg (P = 0.34) 1.11% dabigatran 150 mg (P< 0.001) 0.74% warfarin 0.23% dabigatran 110mg (P< 0.001) 0.3% dabigatran 150 mg (P< 0.001) 3.57% warfarin 2.87% dabigatran 110mg (P = 0.003) 3.32% dabigatran 150 mg (P=0.31)
ROCKET AF9 Rivaroxaban 20 mg once a day Dose-adjusted warfarin 2.42% warfarin 2.12% rivaroxaban (P=0.117) 0.74% warfarin 0.49% rivaroxaban (P= 0.019) 3.45% warfarin 3.6% rivaroxaban (P= 0.576)
ARISTOTLE16 Apixaban 5 mg BID Dose-adjusted warfarin 1.60 warfarin 1.27% apixaban (P< 0.001) 0.47% warfarin 0.24% apixaban 3.09% warfarin 2.13% apixaban (P< 0.001)
AVERROES19 Apixaban 5 mg BID Aspirin (81–324 mg daily) 3.9% aspirin 1.7% apixaban (P< 0.001) 0.3% aspirin 0.4% apixaban (P=0.83) 1.2% aspirin 1.4% apixaban (P=0.33)

RE-LY, Randomized Evaluation of Longterm Anticoagulant Therapy; ROCKET-AF, Rivaroxaban Once daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation; ARISTOTLE, Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; AVERROES, Apixaban versus aspirin to reduce the risk of stroke; mg, milligram; BID, twice a day.