Dabigatran Etexilate in Patients With Mechanical Heart Valves
- Conditions
- Heart Valve Diseases
- Interventions
- Registration Number
- NCT01452347
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 328
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dabigatran etexilate dabigatran etexilate high dose Patient dose dependent on screening CrCl levels and TT warfarin warfarin 3mg warfarin doses to maintain INR levels Dabigatran etexilate dabigatran etexilate intermediate dose Patient dose dependent on screening CrCl levels and TT Dabigatran etexilate dabigatran etexilate low dose Patient dose dependent on screening CrCl levels and TT warfarin warfarin 5mg warfarin doses to maintain INR levels warfarin warfarin 1mg warfarin doses to maintain INR levels
- Primary Outcome Measures
Name Time Method Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1 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.Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2 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.Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4 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.Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12 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
Name Time Method Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1 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.
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2 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.
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4 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.
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12 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.
Trial Locations
- Locations (40)
1160.113.32005 Boehringer Ingelheim Investigational Site
🇧🇪Gent, Belgium
1160.113.42001 Boehringer Ingelheim Investigational Site
🇨🇿Prague 5, Czech Republic
1160.113.32007 Boehringer Ingelheim Investigational Site
🇧🇪Brussel, Belgium
1160.113.32003 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1160.113.42002 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1160.113.11007 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1160.113.42004 Boehringer Ingelheim Investigational Site
🇨🇿Ostrava, Czech Republic
1160.113.46004 Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Sweden
1160.113.46003 Skånes Universitetssjukhus Lund
🇸🇪Lund, Sweden
1160.113.45002 Boehringer Ingelheim Investigational Site
🇩🇰Odense C, Denmark
1160.113.45001 Boehringer Ingelheim Investigational Site
🇩🇰Copenhagen, Denmark
1160.113.11011 Boehringer Ingelheim Investigational Site
🇨🇦London, Ontario, Canada
1160.113.32001 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
1160.113.11002 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1160.113.11009 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1160.113.33001 Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 18, France
1160.113.33003 Boehringer Ingelheim Investigational Site
🇫🇷Rennes Cedex 2, France
1160.113.49002 Boehringer Ingelheim Investigational Site
🇩🇪Essen, Germany
1160.113.11001 Boehringer Ingelheim Investigational Site
🇨🇦Saint John, New Brunswick, Canada
1160.113.11012 Boehringer Ingelheim Investigational Site
🇨🇦Newmarket, Ontario, Canada
1160.113.33004 Boehringer Ingelheim Investigational Site
🇫🇷Bron, France
1160.113.49001 Boehringer Ingelheim Investigational Site
🇩🇪Dresden, Germany
1160.113.11006 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
1160.113.32002 Boehringer Ingelheim Investigational Site
🇧🇪Genk, Belgium
1160.113.33002 Boehringer Ingelheim Investigational Site
🇫🇷Pessac, France
1160.113.42005 Boehringer Ingelheim Investigational Site
🇨🇿Hradec Kralove, Czech Republic
1160.113.42003 Boehringer Ingelheim Investigational Site
🇨🇿Olomouc, Czech Republic
1160.113.47001 Boehringer Ingelheim Investigational Site
🇳🇴Oslo, Norway
1160.113.48004 Boehringer Ingelheim Investigational Site
🇵🇱Gdansk, Poland
1160.113.31001 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1160.113.31002 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1160.113.31004 Boehringer Ingelheim Investigational Site
🇳🇱Breda, Netherlands
1160.113.49008 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt am Main, Germany
1160.113.47002 Boehringer Ingelheim Investigational Site
🇳🇴Bergen, Norway
1160.113.48001 Boehringer Ingelheim Investigational Site
🇵🇱Wroclaw, Poland
1160.113.48003 Boehringer Ingelheim Investigational Site
🇵🇱Warszawa, Poland
1160.113.46001 Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
1160.113.49003 Boehringer Ingelheim Investigational Site
🇩🇪Heidelberg, Germany
1160.113.49004 Boehringer Ingelheim Investigational Site
🇩🇪Freiburg, Germany
1160.113.49010 Boehringer Ingelheim Investigational Site
🇩🇪Witten, Germany