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Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02104947
First received: April 2, 2014
Last updated: November 15, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Hemorrhage
Drug: idarucizumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of dTT or ECT, at any time point from the end of the first infusion up to 4 hours after the last infusion. [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reversal of Activated Partial Thromboplastin Time (aPTT) [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]
  • Reversal of Thrombin Time (TT) [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]
  • Duration of reversal [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
  • Occurrence of major bleeding (for group B only) intraoperatively and up to 24 hours post-surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Time to cessation of bleeding (for Group A only) [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
  • Minimum unbound sum (free) dabigatran [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]
  • Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first infusion and before the start of the second [ Time Frame: up to 15 minutes ] [ Designated as safety issue: No ]

Enrollment: 513
Study Start Date: May 2014
Estimated Study Completion Date: November 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: idarucizumab
idarucizumab Only 1 treatment, no placebo or comparator
Drug: idarucizumab
idarucizumab

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Group A (Bleeding patients)

    • Overt bleeding judged by the physician to require a reversal agent
    • Currently taking dabigatran etexilate
    • At least 18 years of age
    • Written informed consent
  • Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or procedure for a condition other than bleeding

    • Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
    • Current treatment with dabigatran
    • At least 18 years of age
    • Written Informed consent.

Exclusion criteria:

  • Group A (Bleeding Patients)

    • Patients with minor bleeds (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.
  • Group B (Patients who require emergency surgery or procedure)

    • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104947

  Show 166 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02104947     History of Changes
Other Study ID Numbers: 1321.3  2013-004813-41 
Study First Received: April 2, 2014
Last Updated: November 15, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Human Research Ethics Committee
Austria: Austrian Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Denmark: The Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut
Hong Kong: Department of Health
India: Drugs Controller General of India
Ireland: Health Products Regulatory Authority (HPRA)
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: AIFA (Italian Medicine Agency)
Japan: Ministry of Health, Labor and Welfare
Korea: Ministry of Food and Drug Safety
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Health and Disability Ethics Committees
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Pharmacological Committee, Ministry of Health
Singapore: Health Sciences Authority
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines and Medical Devices
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Federal Government
United States: Food and Drug Administration
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Afghanistan: Ministry of Public Health

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Dabigatran
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 05, 2016