Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

• Status: Completed
• Trial end date: 2016-10-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Anticoagulants; Dabigatran

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).