Dabigatran Etexilate in Patients With Mechanical Heart Valves

Heart Valve Diseases Clinical Trial

— RE-ALIGN  

Official title:

A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01452347
• Other study ID #: 1160.113
• Secondary ID: 2010-022685-27
• Status: Terminated
• Phase: Phase 2
• First received: October 11, 2011
• Last updated: July 11, 2014
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal and Health ProductsCanada: Health CanadaCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNetherlands: Central Committee Research Involving Human SubjectsNorway: Norwegian Medicines AgencyPoland: Registration Medicinal Product Medical Device Biocidal ProductSweden: Medical Products AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 328
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Drug:
• warfarin 1mg
comparator warfarin
• dabigatran etexilate intermediate dose
active treatment (medium)
• dabigatran etexilate low dose
active treatment (low)
• warfarin 5mg
comparator warfarin
• dabigatran etexilate high dose
active treatment (high)
• warfarin 3mg
comparator warfarin

Locations

Country	Name	City	State
Belgium	1160.113.32007 Boehringer Ingelheim Investigational Site	Brussel
Belgium	1160.113.32003 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1160.113.32002 Boehringer Ingelheim Investigational Site	Genk
Belgium	1160.113.32005 Boehringer Ingelheim Investigational Site	Gent
Belgium	1160.113.32001 Boehringer Ingelheim Investigational Site	Leuven
Canada	1160.113.11002 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1160.113.11009 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1160.113.11011 Boehringer Ingelheim Investigational Site	London	Ontario
Canada	1160.113.11012 Boehringer Ingelheim Investigational Site	Newmarket	Ontario
Canada	1160.113.11001 Boehringer Ingelheim Investigational Site	Saint John	New Brunswick
Canada	1160.113.11007 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1160.113.11006 Boehringer Ingelheim Investigational Site	Winnipeg	Manitoba
Czech Republic	1160.113.42002 Boehringer Ingelheim Investigational Site	Brno
Czech Republic	1160.113.42005 Boehringer Ingelheim Investigational Site	Hradec Kralove
Czech Republic	1160.113.42003 Boehringer Ingelheim Investigational Site	Olomouc
Czech Republic	1160.113.42004 Boehringer Ingelheim Investigational Site	Ostrava
Czech Republic	1160.113.42001 Boehringer Ingelheim Investigational Site	Prague 5
Denmark	1160.113.45001 Boehringer Ingelheim Investigational Site	Copenhagen
Denmark	1160.113.45002 Boehringer Ingelheim Investigational Site	Odense C
France	1160.113.33004 Boehringer Ingelheim Investigational Site	Bron
France	1160.113.33001 Boehringer Ingelheim Investigational Site	Paris cedex 18
France	1160.113.33002 Boehringer Ingelheim Investigational Site	Pessac
France	1160.113.33003 Boehringer Ingelheim Investigational Site	Rennes Cedex 2
Germany	1160.113.49001 Boehringer Ingelheim Investigational Site	Dresden
Germany	1160.113.49002 Boehringer Ingelheim Investigational Site	Essen
Germany	1160.113.49008 Boehringer Ingelheim Investigational Site	Frankfurt am Main
Germany	1160.113.49004 Boehringer Ingelheim Investigational Site	Freiburg
Germany	1160.113.49003 Boehringer Ingelheim Investigational Site	Heidelberg
Germany	1160.113.49010 Boehringer Ingelheim Investigational Site	Witten
Netherlands	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
Norway	1160.113.47002 Boehringer Ingelheim Investigational Site	Bergen
Norway	1160.113.47001 Boehringer Ingelheim Investigational Site	Oslo
Poland	1160.113.48004 Boehringer Ingelheim Investigational Site	Gdansk
Poland	1160.113.48003 Boehringer Ingelheim Investigational Site	Warszawa
Poland	1160.113.48001 Boehringer Ingelheim Investigational Site	Wroclaw
Sweden	1160.113.46004 Sahlgrenska Universitetssjukhuset	Göteborg
Sweden	1160.113.46003 Skånes Universitetssjukhus Lund	Lund
Sweden	1160.113.46001 Akademiska Sjukhuset	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Netherlands,  Norway,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at 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.	Week 1	No
Primary	Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at 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.	Week 2	No
Primary	Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at 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.	Week 4	No
Primary	Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at 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.	Week 12	No
Secondary	Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at 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.	Week 1	No
Secondary	Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at 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.	Week 2	No
Secondary	Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at 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.	Week 4	No
Secondary	Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) 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.	Week 12	No

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