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Journal

Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran.

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Published:25th Mar 2020
Author: Pollack CV Jr, Reilly PA, Bernstein R, Dubiel R, Eikelboom J, Glund S et al.
Ref.:Thromb Haemost. 2015 Jul;114(1):198-205.
DOI:10.1160/TH15-03-0192.

Idarucizumab, a Fab fragment directed against dabigatran, produced rapid and complete reversal of the anticoagulation effect of dabigatran in animals and in healthy volunteers. The Study of the REVERSal Effects of Idarucizumab in Patients on Active Dabigatran (RE-VERSE AD™) is a global phase 3 prospective cohort study aimed at investigating idarucizumab in dabigatran-treated patients who present with uncontrollable or life-threatening bleeding, and in those requiring urgent surgery or intervention. We describe the rationale for, and design of the trial (clinicaltrials.gov NCT02104947).


Related study: Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

Read abstract on library site