Clinical Trials List
Protocol Number1321.3
NCT Number(ClinicalTrials.gov Identfier)NCT02104947
2014-04-15 - 2017-12-31
Phase III
Terminated5
ICD-10I82.90
Acute embolism and thrombosis of unspecified vein
ICD-10I82.91
Chronic embolism and thrombosis of unspecified vein
ICD-9453.9
Embolism and thrombosis of unspecified site
A Phase III, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0 g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
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Trial Applicant
Boehringer Ingelheim
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Sponsor
Boehringer Ingelheim
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 林幸榮 Division of Cardiovascular Diseases
- Tse-Min Lu Division of Cardiovascular Diseases
- I-Ming Chen Division of Cardiovascular Surgery
- Tze-Fan Chao Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- Ju-Pin Pan Division of Cardiovascular Diseases
- Shih-Hsien Sung Division of Cardiovascular Diseases
- Kang-Ling Wang Division of Cardiovascular Diseases
- 張效煌 Division of Cardiovascular Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 梁馨月 Division of Cardiovascular Diseases
- 林晏年 Division of Cardiovascular Diseases
- Pei-Ying Pai Division of Cardiovascular Diseases
- 吳宏彬 Division of Cardiovascular Diseases
- Lien-Cheng Hsiao Division of Cardiovascular Diseases
- 盧炯睿 Division of Cardiovascular Diseases
- 王宇澄 Division of Cardiovascular Diseases
- Po-Yen Ko Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 邱昱偉 Division of Cardiovascular Diseases
- 杜宗明 Division of Cardiovascular Diseases
- 柯欣榮 Division of Cardiovascular Diseases
- 劉崢偉 Division of Cardiovascular Diseases
- 許榮城 Division of Cardiovascular Diseases
- 陳運淇 Division of Cardiovascular Diseases
- 劉芫宏 Division of Cardiovascular Diseases
- 廖本智 Division of Cardiovascular Diseases
- 林俊忠 Division of Cardiovascular Diseases
- 張藝耀 Division of Cardiovascular Diseases
- 莊文博 Division of Cardiovascular Diseases
- 林恆旭 Division of Cardiovascular Diseases
- 黃姍惠 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 朱志生 Division of Cardiovascular Diseases
- 鄭凱鴻 Division of Cardiovascular Diseases
- 溫文才 Division of Cardiovascular Diseases
- 顏學偉 Division of Cardiovascular Diseases
- Po-Chao Hsu Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- Cheng-An Chiu Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- Tsung-Hsien Lin Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林俊立 Division of Cardiovascular Diseases
- CHIA-TI TSAI Division of Cardiovascular Diseases
- CHIEN-HUA HUANG Division of Cardiovascular Diseases
- Chih-Fan Yeh Division of Cardiovascular Diseases
- LIAN-YU LIN Division of Cardiovascular Diseases
- 劉言彬 Division of Cardiovascular Diseases
- Tzung-Dau Wang Division of Cardiovascular Diseases
- SUNG-CHUN TANG Division of Neurology
- JYH-MING JIMMY JUANG Division of Cardiovascular Diseases
- CHO-KAI WU Division of Cardiovascular Diseases
- YEN-HUNG LIN Division of Cardiovascular Diseases
- Jiann-Shing Jeng Division of Neurology
- Juey-Jen Hwang Division of Cardiovascular Diseases
- WEI-TIEN CHANG Division of Cardiovascular Diseases
- 陳盈憲 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Antidote for dabigatran
Objectives
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.
Test Drug
Idarucizumab (BI 655075)
Active Ingredient
Idarucizumab (BI 655075)
Dosage Form
Concentrate for infusion
Dosage
50
Endpoints
Primary Outcome Measures :
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT [ Time Frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1 ]
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion.
Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients).
Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.
Secondary Outcome Measures :
Reversal of aPTT and TT From Central Laboratory [ Time Frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1 ]
Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients).
Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.
Duration of Reversal [ Time Frame: from the first infusion up to 24 hours after the last infusion on Day 1 ]
Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.
Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively [ Time Frame: within 24 hours of surgery ]
Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH [International Society for Thrombosis and Hemostasis] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.
Time to Cessation of Bleeding (for Group A Only) [ Time Frame: from the first infusion up to 24 hours after the last infusion on Day 1 ]
Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.
Cmin,1 of Unbound Sum (Free) Dabigatran [ Time Frame: Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial ]
Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.
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 [ Time Frame: after the first vial of idarucizumab and before the start of second vial on Day1 ]
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.
Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100*(pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT [ Time Frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1 ]
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion.
Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients).
Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.
Secondary Outcome Measures :
Reversal of aPTT and TT From Central Laboratory [ Time Frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1 ]
Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients).
Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.
Duration of Reversal [ Time Frame: from the first infusion up to 24 hours after the last infusion on Day 1 ]
Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.
Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively [ Time Frame: within 24 hours of surgery ]
Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH [International Society for Thrombosis and Hemostasis] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.
Time to Cessation of Bleeding (for Group A Only) [ Time Frame: from the first infusion up to 24 hours after the last infusion on Day 1 ]
Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.
Cmin,1 of Unbound Sum (Free) Dabigatran [ Time Frame: Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial ]
Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.
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 [ Time Frame: after the first vial of idarucizumab and before the start of second vial on Day1 ]
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.
Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100*(pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.
Inclution 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.
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
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).
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).
The Estimated Number of Participants
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Taiwan
3 participants
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Global
200 participants
