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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01452347
Recruitment Status : Terminated
First Posted : October 14, 2011
Results First Posted : August 6, 2014
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1 [ Time Frame: Week 1 ]

    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.


  2. Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2 [ Time Frame: Week 2 ]

    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.


  3. Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4 [ Time Frame: Week 4 ]

    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.


  4. Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12 [ Time Frame: Week 12 ]

    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 :
  1. Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1 [ Time Frame: Week 1 ]
    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.

  2. Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2 [ Time Frame: Week 2 ]
    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.

  3. Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4 [ Time Frame: Week 4 ]
    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.

  4. Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12 [ Time Frame: Week 12 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452347


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01452347    
Other Study ID Numbers: 1160.113
2010-022685-27 ( EudraCT Number: EudraCT )
First Posted: October 14, 2011    Key Record Dates
Results First Posted: August 6, 2014
Last Update Posted: August 6, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Warfarin
Dabigatran
Anticoagulants
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action