Reversal of dabigatran anticoagulant effect with idarucizumab

Phase 1

Conditions: Hemorrhage
MedDRA version: 18.1Level: LLTClassification code 10019524Term: HemorrhageSystem Organ Class: 100000004866
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-004813-41-AT

Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

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 invasive 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

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 (subjects with hereditary fructose intolerance may react to sorbitol).
- Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or invasive procedure for a condition other than bleeding)
-- A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
-- Contraindications to study medication including known hypersensitiity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the reversal of the anticoagulant effect of dabigatran in patients after administration of idarucizumab;Secondary Objective: The secondary objectives are the assessment of bleeding, clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.;Primary end point(s): 1: Reversal of anticoagulant effect of dabigatran<br>;Timepoint(s) of evaluation of this end point: 1: up to 4 hours<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1: Time to cessation of bleeding (for Group A only)<br><br>2: Occurrence of major bleeding (for Group B only) intraoperatively and up to 24 hours post-surgery<br><br>3: Minimum unbound sum (free) dabigatran <br><br>4: Duration of reversal <br><br>5: Reversal of dTT or ECT after the first infusion and before the start of the second<br><br>6: Reversal of aPTT<br><br>7: Reversal of TT;Timepoint(s) of evaluation of this end point: 1: up to 4 hours<br><br>2: up to 15 minutes<br><br>3: up to 4 hours<br><br>4: up to 4 hours<br><br>5: up to 24 hours<br><br>6: up to 24 hours<br><br>7: up to 24 hours<br>