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Thromb Haemost 2015; 114(01): 198-205
DOI: 10.1160/TH15-03-0192
Trial Protocol Design Paper
Schattauer GmbH

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

Charles V. Pollack Jr.
1   Pennsylvania Hospital, Philadelphia, Pennsylvania, USA
,
Paul A. Reilly
2   Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conneticut, USA
,
Richard Bernstein
3   Northwestern University, Chicago, Illinois, USA
,
Robert Dubiel
2   Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conneticut, USA
,
John Eikelboom
4   McMaster University, Hamilton, Ontario, Canada
,
Stephan Glund
5   Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
,
Menno V. Huisman
6   Leiden University Medical Center, Leiden, Netherlands
,
Elaine Hylek
7   Boston University School of Medicine, Boston, Massachusetts, USA
,
Chak-Wah Kam
8   Tuen Mun Hospital, Tuen Mun, NT, Hong Kong
,
Pieter W. Kamphuisen
9   University Medical Center, Groningen, Netherlands
,
Joerg Kreuzer
10   Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
,
Jerrold H. Levy
11   Duke University Medical Center, Durham, North Carolina, USA
,
Frank Sellke
12   Brown Medical School, Providence, Rhode Island, USA
,
Joachim Stangier
5   Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
,
Thorsten Steiner
13   University of Heidelberg, Heidelberg, Germany
,
Bushi Wang
2   Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conneticut, USA
,
Jeffrey I. Weitz
4   McMaster University, Hamilton, Ontario, Canada
› Author Affiliations
Further Information

Publication History

Received: 03 March 2015

Accepted after major revision: 19 May 2015

Publication Date:
22 November 2017 (online)

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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).

 

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