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

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 REVERS al E ffects of Idarucizumab in Patients on A ctive D abigatran (RE-VERSE AD™) is a global phase 3 p...

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Main Authors: Pollack, Charles V. (Author) , Reilly, Paul A. (Author) , Bernstein, Richard (Author) , Dubiel, Robert (Author) , Eikelboom, John (Author) , Glund, Stephan (Author) , Huisman, Menno V. (Author) , Hylek, Elaine (Author) , Kam, Chak-Wah (Author) , Kamphuisen, Pieter W. (Author) , Kreuzer, Joerg (Author) , Levy, Jerrold H. (Author) , Sellke, Frank (Author) , Stangier, Joachim (Author) , Steiner, Thorsten (Author) , Wang, Bushi (Author) , Weitz, Jeffrey I. (Author)
Format: Article (Journal)
Language:English
Published: 2015
In: Thrombosis and haemostasis
Year: 2017, Volume: 114, Issue: 1, Pages: 198-205
ISSN:2567-689X
DOI:10.1160/TH15-03-0192
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1160/TH15-03-0192
Verlag, lizenzpflichtig, Volltext: http://www.thieme-connect.de/DOI/DOI?10.1160/TH15-03-0192
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Author Notes:Charles V. Pollack Jr, Paul A. Reilly, Richard Bernstein, Robert Dubiel, John Eikelboom, Stephan Glund, Menno V. Huisman, Elaine Hylek, Chak-Wah Kam, Pieter W. Kamphuisen, Joerg Kreuzer, Jerrold H. Levy, Frank Sellke, Joachim Stangier, Thorsten Steiner, Bushi Wang, Jeffrey I. Weitz
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Summary: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 REVERS al E ffects of Idarucizumab in Patients on A ctive D abigatran (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).
Item Description:Publikationsdatum: 22. November 2017
Gesehen am 22.07.2020
Physical Description:Online Resource
ISSN:2567-689X
DOI:10.1160/TH15-03-0192