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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01452347
First received: October 11, 2011
Last updated: July 11, 2014
Last verified: July 2014
History of Changes
  Purpose
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:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

    Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) .

    Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.


  • Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

    Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).

    Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.


  • Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).

    Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.


  • Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).

    (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients)

    Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.



Secondary Outcome Measures:
  • Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.

  • Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.

  • Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.

  • Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Percentage of patients with observed Ctrough,ss value < 50 ng/mL (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) This outcome measure was only analysed for all patients together and not by dose group.
Enrollment: 328
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

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01452347

  Show 40 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: NCT01452347     History of Changes
Other Study ID Numbers: 1160.113  2010-022685-27 
Study First Received: October 11, 2011
Results First Received: May 23, 2014
Last Updated: July 11, 2014
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
Dabigatran
Warfarin
Antithrombins
 Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on September 30, 2016