This trial is active, not recruiting.

Condition hemorrhage
Treatment idarucizumab
Phase phase 3
Sponsor Boehringer Ingelheim
Start date May 2014
End date July 2016
Trial size 513 participants
Trial identifier NCT02104947, 1321.3, 2013-004813-41


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
idarucizumab Only 1 treatment, no placebo or comparator

Primary Outcomes

Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of dTT or ECT, at any time point from the end of the first infusion up to 4 hours after the last infusion.
time frame: up to 4 hours

Secondary Outcomes

Reversal of Activated Partial Thromboplastin Time (aPTT)
time frame: up to 4 hours
Reversal of Thrombin Time (TT)
time frame: up to 4 hours
Duration of reversal
time frame: up to 24 hours
Occurrence of major bleeding (for group B only) intraoperatively and up to 24 hours post-surgery
time frame: 24 hours
Time to cessation of bleeding (for Group A only)
time frame: up to 24 hours
Minimum unbound sum (free) dabigatran
time frame: up to 4 hours
Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first infusion and before the start of the second
time frame: up to 15 minutes

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Group A (Bleeding patients) - Overt bleeding judged by the physician to require a reversal agent - Currently taking dabigatran etexilate - At least 18 years of age - Written informed consent - Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or procedure for a condition other than bleeding - Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours. - Current treatment with dabigatran - At least 18 years of age - Written Informed consent. Exclusion criteria: - Group A (Bleeding Patients) - Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care. - Patients with no clinical signs of bleeding - Contraindications to study medication including known hypersensitivity to the drug or its excipients. - Group B (Patients who require emergency surgery or procedure) - A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low. - Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.