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Dabigatran Etexilate in Patients With Mechanical Heart Valves

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01452347
First received: October 11, 2011
Last updated: February 4, 2013
Last verified: January 2013
History of Changes

October 11, 2011
February 4, 2013
October 2011
November 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01452347 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Dabigatran Etexilate in Patients With Mechanical Heart Valves
A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt

To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

Based on an interim analysis from the phase II, 1160.113 and 1160.138 trials which suggested that the investigated dosing regimen did not achieve the desired results in this patient population, it was decided that from this point forward, patients will discontinue study medication and be followed up for a further six months.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Heart Valve Diseases
  • Drug: warfarin 1mg
    comparator warfarin
  • Drug: dabigatran etexilate intermediate dose
    active treatment (medium)
  • Drug: dabigatran etexilate low dose
    active treatment (low)
  • Drug: warfarin 5mg
    comparator warfarin
  • Drug: dabigatran etexilate high dose
    active treatment (high)
  • Drug: warfarin 3mg
    comparator warfarin
  • Experimental: Dabigatran etexilate
    Patient dose dependent on screening CrCl levels and TT
    Interventions:
    • Drug: dabigatran etexilate intermediate dose
    • Drug: dabigatran etexilate low dose
    • Drug: dabigatran etexilate high dose
  • Active Comparator: warfarin
    warfarin doses to maintain INR levels
    Interventions:
    • Drug: warfarin 1mg
    • Drug: warfarin 5mg
    • Drug: warfarin 3mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
253
Not Provided
November 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Patients aged 18-75
  2. Patients who have received a bileaflet mechanical heart valve

Exclusion criteria:

  1. Prior valve surgery
  2. Uncontrolled hypertension
  3. severe renal impairment
  4. active liver disease
  5. increased risk of bleeding
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Netherlands,   Norway,   Poland,   Sweden
 
NCT01452347
1160.113, 2010-022685-27
Not Provided
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP