Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Hemorrhage

Treatments

Drug: idarucizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02104947

2013-004813-41 (EudraCT Number)

1321.3

Details and patient eligibility

About

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.

Enrollment

503 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).