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Clinical trial

Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

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Last updated:1st May 2014
Identifier: NCT02104947

Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
 

Study Type: Interventional
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial
Estimated Enrollment: 300
Study Start Date: May 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)

Arm:
- Experimental:
idarucizumab


Related journals:
- Idarucizumab for Dabigatran Reversal

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

-
Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding.

Category Value
Date last updated at source 2018-01-05
Study type(s) Interventional
Expected enrolment 300
Study start date 2014-05-01
Estimated primary completion date 2017-07-01

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