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Study design of RE-ALIGN
Study treatment
Start
warfarin up Warfarin
to day 7 (INR according to guidelines)
Population A 1 week
CrCl < 70 mL/min: follow-up or
transition to
DE 150 mg bid
RE-ALIGN
extension
CrCl 70 < 110 mL/min: trial
Population B DE 220 mg bid
SE, n (%) 0 0 0 0 0 0
6
Possible explanations for
negative study results
7
Prosthetic valves and contact activation
Dabigatran vs. Warfarin
Contact Injury
Intrinsic Extrinsic
IXa/VIIIa TF/VIIa
Tenase Tenase
X X
Xa Prothrombinase
Warfarin
Thrombin Dabigatran
Clot formation
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NEJM, September 1st, 2013