This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding

Phase 3

Completed

• Conditions: Hemorrhage
• Interventions: Drug: Idarucizumab

• Registration Number: NCT03343704
• Lead Sponsor: Boehringer Ingelheim

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 urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure.

The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Study Start: 2018-03-26
• Primary Completion: 2020-07-02
• Study Completion: 2020-07-02
• Results First Submitted: 2021-06-29
• Results First Submitted QC: 2021-07-28
• Results First Posted: 2021-08-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B - patients not bleeding but requiring emergency surgery or invasive procedure	Idarucizumab	-
Group A - patients with uncontrolled or life-threatening bleeding	Idarucizumab	-

Primary Outcome Measures

Name	Time	Method
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time	From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.	Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of ecarin clotting time is reported.; The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is \> 100, it was set to 100. 100% ULN is 41.26 seconds.
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time	From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.	Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time is reported.; The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is \> 100, it was set to 100. 100% ULN is 35.54 seconds.

Secondary Outcome Measures

Name	Time	Method
Numbers of Participants With Any Adverse Events - Including Post Treatment Period	Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.	Numbers of participants with any adverse events until end of study is reported.
Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only)	Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period.	Percentage of participants achieving cessation of bleeding within 24 hours after completion of second infusion for Group A is reported.
Number of Participants With Major Bleeding (for Group B Only) Intra-operatively and up to 24 Hours Post-surgery	Up to 24 hours post-surgery.	Number of participants with major bleeding (for Group B only) intra-operatively and up to 24 hours post-surgery per International Society for Thrombosis and Hemostasis (ISTH) classification is reported.
Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)	From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.	Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported.; The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is \> 100, it was set to 100. 100% ULN is 39.80 seconds.
Numbers of Participants With Any Adverse Events - on Treatment	Since the first infusion up until 5 days after the completion of the second infusion.	Numbers of participants with any adverse events during on treatment period is reported.
Number of Participants With Thrombotic Events - on Treatment	Since the first infusion up until 5 days after the completion of the second infusion.	Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) during on treatment period is reported.
Number of Participants With Serious Adverse Events - on Treatment	Since the first infusion up until 5 days after the completion of the second infusion.	Number of participants with Serious adverse events during on treatment period is reported.
Minimum Unbound Sum Dabigatran Concentrations Since the End of First Infusion up to 4 Hours After the Completion of the Last Infusion (Cmin,1)	Just prior to the second infusion (last infusion) and 10 minutes (min), 30 min, 1 hour (h), 2 h, and 4 h after the end of the second infusion.	Minimum unbound sum dabigatran concentrations since the end of first infusion up to 4 hours after the completion of the last infusion (Cmin,1) is reported.
Maximum Reversal of Anticoagulation as Measured by Thrombin Time (TT)	From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.	Maximum reversal of anticoagulation as measured by thrombin time (TT) is reported.; The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If calculated reversal is \> 100, it was set to 100. 100% ULN is 14.22 seconds.
Number of Participants With Drug-related Adverse Events - on Treatment	Since the first infusion up until 5 days after the completion of the second infusion.	Numbers of patients with drug-related adverse events during on treatment period is reported.
Number of Participants With Drug-related Adverse Events - Including Post Treatment Period	Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.	Numbers of patients with drug-related adverse events until end of study is reported.
Number of Participants With Immune Reaction Adverse Event - on Treatment	Since the first infusion up until 5 days after the completion of the second infusion.	Number of participants with immune reaction adverse event during on treatment period is reported.
Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period	Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.	Number of participants with immune reaction adverse event until end of study is reported.
Number of Participants With Thrombotic Events - Including Post Treatment Period	Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.	Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) until end of study is reported.
Number of Participants With Serious Adverse Events - Including Post Treatment Period	Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.	Number of participants with Serious adverse events until the end of study is reported.

Trial Locations

Locations (13)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, China

Cardiovascular Institute and Fu Wai Hospital; 🇨🇳 Beijing, China

Beijing AnZhen Hospital; 🇨🇳 Beijing, China

2nd Affiliated Hosp Zhejiang University College of Medical; 🇨🇳 Hangzhou, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu Province, China

The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Urumqi, China

Zhejiang Province People's Hospital; 🇨🇳 Hangzhou, China

Sun yet-sen Memorial Hospital, Sun yet-sen Univesity; 🇨🇳 Guangzhou, China

First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, China

The Second Affiliated Hospital to Nanchang University; 🇨🇳 Nanchang, China

The First Affiliated Hospital of Wenzhou Med College; 🇨🇳 Wenzhou, China

Shanghai First People's Hospital; 🇨🇳 Shanghai, China

Peking University First Hospital; 🇨🇳 Beijing, China