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

NCT03343704 | Completed Phase 3 Results

• 1 other identifier: 1321-0019
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 13

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.

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.

Secondary Outcomes (15)

• 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.

• 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.

• 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.

• 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 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.

Study Arms (2)

Group A - patients with uncontrolled or life-threatening bleeding

EXPERIMENTAL

Drug: Idarucizumab

Group B - patients not bleeding but requiring emergency surgery or invasive procedure

EXPERIMENTAL

Drug: Idarucizumab

Interventions

Idarucizumab DRUG

Intravenous

Also known as: PRAXBIND, Praxbind, Prizbind

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (13)

Beijing AnZhen Hospital

Beijing, 100029, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Cardiovascular Institute and Fu Wai Hospital

Beijing, 100037, China

Location

First Affiliated Hospital of Dalian Medical University

Dalian, 116011, China

Location

Guangdong Provincial People's Hospital

Guangzhou, 510080, China

Location

Sun yet-sen Memorial Hospital, Sun yet-sen Univesity

Guangzhou, 510288, China

Location

2nd Affiliated Hosp Zhejiang University College of Medical

Hangzhou, 310009, China

Location

Zhejiang Province People's Hospital

Hangzhou, 310014, China

Location

The Second Affiliated Hospital to Nanchang University

Nanchang, 330006, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu Province, 210029, China

Location

Shanghai First People's Hospital

Shanghai, 200080, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, 830054, China

Location

The First Affiliated Hospital of Wenzhou Med College

Wenzhou, 325000, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hemorrhage

Interventions

idarucizumab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: March 26, 2018
• Primary Completion: July 2, 2020
• Study Completion: July 2, 2020
• Last Updated: February 25, 2025
• Results First Posted: August 20, 2021

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)