Dabigatran Etexilate in Patients With Mechanical Heart Valves (RE-ALIGN)

This study has been terminated.
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
First received: October 11, 2011
Last updated: August 29, 2013
Last verified: August 2013

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

Condition Intervention Phase
Heart Valve Diseases
Drug: warfarin 1mg
Drug: dabigatran etexilate intermediate dose
Drug: dabigatran etexilate low dose
Drug: warfarin 5mg
Drug: dabigatran etexilate high dose
Drug: warfarin 3mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Total dabigatran concentration at trough [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: October 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran etexilate
Patient dose dependent on screening CrCl levels and TT
Drug: dabigatran etexilate intermediate dose
active treatment (medium)
Drug: dabigatran etexilate low dose
active treatment (low)
Drug: dabigatran etexilate high dose
active treatment (high)
Active Comparator: warfarin
warfarin doses to maintain INR levels
Drug: warfarin 1mg
comparator warfarin
Drug: warfarin 5mg
comparator warfarin
Drug: warfarin 3mg
comparator warfarin


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01452347

  Show 40 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01452347     History of Changes
Other Study ID Numbers: 1160.113, 2010-022685-27
Study First Received: October 11, 2011
Last Updated: August 29, 2013
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Poland: Registration Medicinal Product Medical Device Biocidal Product
Sweden: Medical Products Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014