At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 503 enrolled
Drug / intervention
idarucizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating idarucizumab for Hemorrhage. Completed, enrolled 503 participants across 176 sites in 33 countries.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhage
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartMay 2014
Primary CompletionJul 2016
Study CompletionOct 2016
TodayJul 2026
First PostedApr 7, 2014
Enrollment StartMay 6, 2014
Primary CompletionJul 25, 2016
Study CompletionOct 20, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.2 years ago
Interventions
idarucizumabdrug
idarucizumab