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Trial record 1 of 1 for:    NCT01452347
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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

October 11, 2011
July 11, 2014
October 2011
June 2013   (final data collection date for primary outcome measure)
  • 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.

Not Provided
Complete list of historical versions of study NCT01452347 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
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
Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt JU, Simoons ML, Van de Werf F; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sep 26;369(13):1206-14. doi: 10.1056/NEJMoa1300615. Epub 2013 Aug 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
328
June 2013
June 2013   (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
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

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