Status:
COMPLETED
This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring ur...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- ≥ 18 years at screening.
- Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Currently taking dabigatran etexilate
- They meet the following criteria:
- Group A: Overt bleeding judged by the physician to require a reversal agent. OR
- Group B: A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
- Exclusion criteria:
- Group A:
- Patients with minor bleeding (e.g. 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:
- 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).
Exclusion
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03343704
Start Date
March 26 2018
End Date
July 2 2020
Last Update
February 25 2025
Active Locations (13)
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1
Beijing AnZhen Hospital
Beijing, China, 100029
2
Peking University First Hospital
Beijing, China, 100034
3
Cardiovascular Institute and Fu Wai Hospital
Beijing, China, 100037
4
First Affiliated Hospital of Dalian Medical University
Dalian, China, 116011