Phase 3 N=19 Treatment

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

Hemorrhage

Bottom Line

View on ClinicalTrials.gov: NCT03343704 ↗

Enrolled (actual)

Serious AEs

52.6%

Results posted

Aug 2021

Primary outcome: Primary: Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time — 100.0; 100.0; 100.0 Percentage

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Idarucizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Jul 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time	100.0; 100.0; 100.0	—
PRIMARY Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time	100.0; 100.0; 100.0	—
SECONDARY Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only)	55.6	—
SECONDARY Number of Participants With Major Bleeding (for Group B Only) Intra-operatively and up to 24 Hours Post-surgery	0; 1; 0; 0	—
SECONDARY 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; 1	—
SECONDARY Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)	100; 100; 100	—
SECONDARY Maximum Reversal of Anticoagulation as Measured by Thrombin Time (TT)	100; 100; 100	—
SECONDARY Numbers of Participants With Any Adverse Events - on Treatment	11; 6	—
SECONDARY Numbers of Participants With Any Adverse Events - Including Post Treatment Period	13; 6	—
SECONDARY Number of Participants With Serious Adverse Events - on Treatment	3; 1	—
SECONDARY Number of Participants With Serious Adverse Events - Including Post Treatment Period	7; 3	—
SECONDARY Number of Participants With Drug-related Adverse Events - on Treatment	2; 1	—
SECONDARY Number of Participants With Drug-related Adverse Events - Including Post Treatment Period	2; 1	—
SECONDARY Number of Participants With Immune Reaction Adverse Event - on Treatment	3; 0	—
SECONDARY Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period	3; 0	—
SECONDARY Number of Participants With Thrombotic Events - on Treatment	1; 1	—
SECONDARY Number of Participants With Thrombotic Events - Including Post Treatment Period	2; 3	—

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.

Eligibility Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03343704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.