A Phase 3 interventional study of Idarucizumab in Hemorrhage, sponsored by Boehringer Ingelheim. Completed at 13 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
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.
They meet the following criteria:
Exclusion criteria:
Group A:
Group B:
Drug: Idarucizumab
Drug: Idarucizumab
Intravenous
Also known as: PRAXBIND, Praxbind, Prizbind
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time
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.
Time frame: 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
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.
Time frame: From the end of first infusion up to 4 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 Only)
Percentage of participants achieving cessation of bleeding within 24 hours after completion of second infusion for Group A is reported.
Time frame: Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period.
Number of Participants With Major Bleeding (for Group B Only) Intra-operatively and 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.
Time frame: Up to 24 hours post-surgery.
Minimum Unbound Sum Dabigatran Concentrations Since the End of First Infusion up to 4 Hours After the Completion of the Last Infusion (Cmin,1)
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.
Time frame: 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.
Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
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.
Time frame: 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)
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.
Time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Numbers of Participants With Any Adverse Events - on Treatment
Numbers of participants with any adverse events during on treatment period is reported.
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Numbers of Participants With Any Adverse Events - Including Post Treatment Period
Numbers of participants with any adverse events until end of study is reported.
Time frame: 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 - on Treatment
Number of participants with Serious adverse events during on treatment period is reported.
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Serious Adverse Events - Including Post Treatment Period
Number of participants with Serious adverse events until the end of study is reported.
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Drug-related Adverse Events - on Treatment
Numbers of patients with drug-related adverse events during on treatment period is reported.
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Drug-related Adverse Events - Including Post Treatment Period
Numbers of patients with drug-related adverse events until end of study is reported.
Time frame: 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 - on Treatment
Number of participants with immune reaction adverse event during on treatment period is reported.
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period
Number of participants with immune reaction adverse event until end of study is reported.
Time frame: 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 - on Treatment
Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) during on treatment period is reported.
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Thrombotic Events - Including Post Treatment Period
Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) until end of study is reported.
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
This study was to demonstrate the reversal of the anticoagulant effects of dabigatran by intravenous administration of idarucizumab in patients treated with dabigatran etexilate who had uncontrolled bleeding or required emergency surgery or procedures over treatment period of 1 day following by 30 days follow-up.
| Milestone | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Started | 13 | 6 |
| Completed | 12 | 4 |
| Not completed | 1 | 2 |
| Withdrew: Refused to complete follow up | 0 | 1 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Reluctant to collect blood and received telephone follow up | 1 | 0 |
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.
| Percentage | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | Total |
|---|---|---|---|
| Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time | 100.0 (100.0 to 100.0) | 100.0 (96.8 to 100.0) | 100.0 (100.0 to 100.0) |
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.
| Percentage | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | Total |
|---|---|---|---|
| Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) |
Percentage of participants achieving cessation of bleeding within 24 hours after completion of second infusion for Group A is reported.
| Percentage of participants | Group A - Patients With Uncontrolled or Life-threatening Bleeding |
|---|---|
| Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only) | 55.6 |
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.
| Participants | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|
| Minor | 0 |
| Major | 1 |
| Major, Life -Threatening or Fatal | 0 |
| Not assessable | 0 |
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.
| nanogram per milliliter | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Minimum Unbound Sum Dabigatran Concentrations Since the End of First Infusion up to 4 Hours After the Completion of the Last Infusion (Cmin,1) | 1 ± 0 | 1 ± 0 |
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.
| Percentage | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | Total |
|---|---|---|---|
| Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | 100 (67.9 to 100.0) | 100 (98.3 to 100.0) | 100 (98.3 to 100.0) |
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.
| Percentage | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | Total |
|---|---|---|---|
| Maximum Reversal of Anticoagulation as Measured by Thrombin Time (TT) | 100 (100.0 to 100.0) | 100 (100.0 to 100.0) | 100 (100.0 to 100.0) |
Numbers of participants with any adverse events during on treatment period is reported.
| Participants | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Numbers of Participants With Any Adverse Events - on Treatment | 11 | 6 |
Numbers of participants with any adverse events until end of study is reported.
| Participants | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Numbers of Participants With Any Adverse Events - Including Post Treatment Period | 13 | 6 |
Number of participants with Serious adverse events during on treatment period is reported.
| Participants | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Number of Participants With Serious Adverse Events - on Treatment | 3 | 1 |
Number of participants with Serious adverse events until the end of study is reported.
| Participants | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Number of Participants With Serious Adverse Events - Including Post Treatment Period | 7 | 3 |
Numbers of patients with drug-related adverse events during on treatment period is reported.
| Participants | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Number of Participants With Drug-related Adverse Events - on Treatment | 2 | 1 |
Numbers of patients with drug-related adverse events until end of study is reported.
| Participants | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Number of Participants With Drug-related Adverse Events - Including Post Treatment Period | 2 | 1 |
Number of participants with immune reaction adverse event during on treatment period is reported.
| Participants | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Number of Participants With Immune Reaction Adverse Event - on Treatment | 3 | 0 |
Number of participants with immune reaction adverse event until end of study is reported.
| Participants | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period | 3 | 0 |
Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) during on treatment period is reported.
| Participants | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Number of Participants With Thrombotic Events - on Treatment | 1 | 1 |
Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) until end of study is reported.
| Participants | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| Number of Participants With Thrombotic Events - Including Post Treatment Period | 2 | 3 |
Collected over Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A - Patients With Uncontrolled or Life-threatening Bleeding | 0/13 (0%) | 7/13 (53.8%) | 13/13 (100%) |
| Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | 1/6 (16.7%) | 3/6 (50%) | 6/6 (100%) |
| Event | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 0/13 | 1/6 |
| Cardiac failureCardiac disorders | 0/13 | 1/6 |
| Cardiac failure chronicCardiac disorders | 0/13 | 1/6 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 2/13 | 1/6 |
| Multiple organ dysfunction syndromeGeneral disorders | 0/13 | 1/6 |
| Hepatic function abnormalHepatobiliary disorders | 0/13 | 1/6 |
| PneumoniaInfections and infestations | 1/13 | 1/6 |
| SeizureNervous system disorders | 0/13 | 1/6 |
| Thalamic infarctionNervous system disorders | 0/13 | 1/6 |
| DeliriumPsychiatric disorders | 2/13 | 0/6 |
| Event | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 3/13 | 3/6 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/13 | 2/6 |
| DiarrhoeaGastrointestinal disorders | 2/13 | 2/6 |
| InfectionInfections and infestations | 2/13 | 2/6 |
| Neutrophil percentage increasedInvestigations | 0/13 | 2/6 |
| White blood cell count increasedInvestigations | 0/13 | 2/6 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 3/13 | 2/6 |
| ConstipationGastrointestinal disorders | 4/13 | 0/6 |
| PyrexiaGeneral disorders | 3/13 | 0/6 |
| HypokalaemiaMetabolism and nutrition disorders | 3/13 | 0/6 |
Treated set (TS): include all patients who are administered with idarucizumab.
| Age, Continuous(Years) | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | Total |
|---|---|---|---|
| Mean | 75.4 ± 12.3 | 62.8 ± 10.6 | 71.4 ± 13.0 |
| Sex: Female, Male(Participants) | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 8 | 2 | 10 |
| Race (NIH/OMB)(Participants) | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 13 | 6 | 19 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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