Phase 3
N=503
Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT02104947 ↗Enrolled (actual)
503
Serious AEs
52.9%
Results posted
Aug 2017
Primary outcome: Primary: Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT — 100.0; 100.0; 100.0; 100.0 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- idarucizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT |
100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Reversal of aPTT and TT From Central Laboratory |
100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Duration of Reversal |
13.2; 12.8; 19.8; 18.8 | — |
| SECONDARY Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively |
3.0 | — |
| SECONDARY Time to Cessation of Bleeding (for Group A Only) |
10.73; 2.49 | — |
| SECONDARY Cmin,1 of Unbound Sum (Free) Dabigatran |
1.12 | — |
| SECONDARY Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial |
100.0; 100.0; 100.0; 100.0 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02104947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.