Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

Phase 3

Completed

• Conditions: Hemorrhage
• Interventions: Drug: idarucizumab

• Registration Number: NCT02104947
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Study Start: 2014-05-06
• Primary Completion: 2016-07-25
• Study Completion: 2016-10-20
• Results First Submitted: 2017-07-21
• Results First Submitted QC: 2017-07-21
• Results First Posted: 2017-08-18
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-03
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
idarucizumab	idarucizumab	idarucizumab Only 1 treatment, no placebo or comparator

Primary Outcome Measures

Name	Time	Method
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT	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

Name	Time	Method
Reversal of aPTT and TT From Central Laboratory	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	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	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)	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	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	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.

Trial Locations

Locations (176)

Baptist Health Center for Clinical Research; 🇺🇸 Little Rock, Arkansas, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

University of Florida College of Medicine; 🇺🇸 Gainesville, Florida, United States

Baptist Medical Center; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic Cancer Center; 🇺🇸 Jacksonville, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

St. Joseph's Hospital; 🇺🇸 Tampa, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

OSF Saint Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

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