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

Abstract:

: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).

journal_name

Thromb Haemost

authors

Pollack CV Jr,Reilly PA,Bernstein R,Dubiel R,Eikelboom J,Glund S,Huisman MV,Hylek E,Kam CW,Kamphuisen PW,Kreuzer J,Levy JH,Sellke F,Stangier J,Steiner T,Wang B,Weitz JI

doi

10.1160/TH15-03-0192

subject

Has Abstract

pub_date

2015-07-01 00:00:00

pages

198-205

issue

1

eissn

0340-6245

issn

2567-689X

pii

15-03-0192

journal_volume

114

pub_type

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