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Validation of a Novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy

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ClinicalTrials.gov Identifier: NCT01810237
Recruitment Status : Withdrawn (No patients recruited)
First Posted : March 13, 2013
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Sudeep Shivakumar, Nova Scotia Health Authority

Study Description
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Brief Summary:

Research Questions:

  1. Does using dabigatran bridging result in consistent therapeutic anticoagulation? What percentage of patients will become subtherapeutic on warfarin once dabigatran is stopped?
  2. What is the incidence of bleeding events with the use of dabigatran overlapped with warfarin for bridging?
  3. What is the cost benefit of using dabigatran instead of dalteparin for bridging anticoagulation?

Condition or disease Intervention/treatment Phase
Venous Thromboses Drug: Dabigatran. Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Validation of a Novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy
Study Start Date : March 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dabigtran instead of LMWH for perioperative bridging. Drug: Dabigatran.
Dabigatran will be used instead of LMWH for anticoagulation bridging.


Outcome Measures
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Primary Outcome Measures :
  1. Validation of a novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy [ Time Frame: 1 Year. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low risk status VTE
  • Chronic warfarin therapy of at least 12 months duration with target INR of 2.0-3.0

Exclusion Criteria:

  • Increased risk of bleeding: bleeding requiring transfusion in last 12 months, history of hemorrhagic stroke or intracranial hemorrhage, recent gastrointestinal bleeding {<6 months}, history of a bleeding disorder
  • Pregnant, breastfeeding or planning to become pregnant or breastfeed
  • Inhibitors allergy/sensitivity to dabigatran etexilate
  • Creatinine Clearance < 30 mls/min
  • Concomitant treatment with strong P-glycoprotein
  • Known thrombophilia including Factor V Leiden mutation, prothrombin gene mutation, antithrombin deficiency, protein C deficiency, protein S deficiency, and antiphospholipid antibody syndrome
  • Inability to provide written informed consent
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Responsible Party: Sudeep Shivakumar, MD FRCPC, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01810237     History of Changes
Other Study ID Numbers: SS001
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Dabigatran
 Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action