search
Back to results

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

Primary Purpose

Heart Valve Diseases

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
warfarin 1mg
dabigatran etexilate intermediate dose
dabigatran etexilate low dose
warfarin 5mg
dabigatran etexilate high dose
warfarin 3mg
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Valve Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1160.113.32007 Boehringer Ingelheim Investigational Site
  • 1160.113.32003 Boehringer Ingelheim Investigational Site
  • 1160.113.32002 Boehringer Ingelheim Investigational Site
  • 1160.113.32005 Boehringer Ingelheim Investigational Site
  • 1160.113.32001 Boehringer Ingelheim Investigational Site
  • 1160.113.11002 Boehringer Ingelheim Investigational Site
  • 1160.113.11006 Boehringer Ingelheim Investigational Site
  • 1160.113.11001 Boehringer Ingelheim Investigational Site
  • 1160.113.11009 Boehringer Ingelheim Investigational Site
  • 1160.113.11011 Boehringer Ingelheim Investigational Site
  • 1160.113.11012 Boehringer Ingelheim Investigational Site
  • 1160.113.11007 Boehringer Ingelheim Investigational Site
  • 1160.113.42002 Boehringer Ingelheim Investigational Site
  • 1160.113.42005 Boehringer Ingelheim Investigational Site
  • 1160.113.42003 Boehringer Ingelheim Investigational Site
  • 1160.113.42004 Boehringer Ingelheim Investigational Site
  • 1160.113.42001 Boehringer Ingelheim Investigational Site
  • 1160.113.45001 Boehringer Ingelheim Investigational Site
  • 1160.113.45002 Boehringer Ingelheim Investigational Site
  • 1160.113.33004 Boehringer Ingelheim Investigational Site
  • 1160.113.33001 Boehringer Ingelheim Investigational Site
  • 1160.113.33002 Boehringer Ingelheim Investigational Site
  • 1160.113.33003 Boehringer Ingelheim Investigational Site
  • 1160.113.49001 Boehringer Ingelheim Investigational Site
  • 1160.113.49002 Boehringer Ingelheim Investigational Site
  • 1160.113.49008 Boehringer Ingelheim Investigational Site
  • 1160.113.49004 Boehringer Ingelheim Investigational Site
  • 1160.113.49003 Boehringer Ingelheim Investigational Site
  • 1160.113.49010 Boehringer Ingelheim Investigational Site
  • 1160.113.31001 Boehringer Ingelheim Investigational Site
  • 1160.113.31002 Boehringer Ingelheim Investigational Site
  • 1160.113.31004 Boehringer Ingelheim Investigational Site
  • 1160.113.47002 Boehringer Ingelheim Investigational Site
  • 1160.113.47001 Boehringer Ingelheim Investigational Site
  • 1160.113.48004 Boehringer Ingelheim Investigational Site
  • 1160.113.48003 Boehringer Ingelheim Investigational Site
  • 1160.113.48001 Boehringer Ingelheim Investigational Site
  • 1160.113.46004 Sahlgrenska Universitetssjukhuset
  • 1160.113.46003 Skånes Universitetssjukhus Lund
  • 1160.113.46001 Akademiska Sjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dabigatran etexilate

warfarin

Arm Description

Patient dose dependent on screening CrCl levels and TT

warfarin doses to maintain INR levels

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 11, 2011
Last Updated
July 11, 2014
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT01452347
Brief Title
Dabigatran Etexilate in Patients With Mechanical Heart Valves
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dabigatran etexilate
Arm Type
Experimental
Arm Description
Patient dose dependent on screening CrCl levels and TT
Arm Title
warfarin
Arm Type
Active Comparator
Arm Description
warfarin doses to maintain INR levels
Intervention Type
Drug
Intervention Name(s)
warfarin 1mg
Intervention Description
comparator warfarin
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate intermediate dose
Intervention Description
active treatment (medium)
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate low dose
Intervention Description
active treatment (low)
Intervention Type
Drug
Intervention Name(s)
warfarin 5mg
Intervention Description
comparator warfarin
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate high dose
Intervention Description
active treatment (high)
Intervention Type
Drug
Intervention Name(s)
warfarin 3mg
Intervention Description
comparator warfarin
Primary Outcome Measure Information:
Title
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1
Description
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.
Time Frame
Week 1
Title
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2
Description
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.
Time Frame
Week 2
Title
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4
Description
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.
Time Frame
Week 4
Title
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1
Description
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.
Time Frame
Week 1
Title
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2
Description
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.
Time Frame
Week 2
Title
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4
Description
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.
Time Frame
Week 4
Title
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12
Description
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.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients aged 18-75 Patients who have received a bileaflet mechanical heart valve Exclusion criteria: Prior valve surgery Uncontrolled hypertension severe renal impairment active liver disease increased risk of bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.113.32007 Boehringer Ingelheim Investigational Site
City
Brussel
Country
Belgium
Facility Name
1160.113.32003 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1160.113.32002 Boehringer Ingelheim Investigational Site
City
Genk
Country
Belgium
Facility Name
1160.113.32005 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
1160.113.32001 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
1160.113.11002 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1160.113.11006 Boehringer Ingelheim Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
1160.113.11001 Boehringer Ingelheim Investigational Site
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
1160.113.11009 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.113.11011 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1160.113.11012 Boehringer Ingelheim Investigational Site
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
1160.113.11007 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1160.113.42002 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czech Republic
Facility Name
1160.113.42005 Boehringer Ingelheim Investigational Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
1160.113.42003 Boehringer Ingelheim Investigational Site
City
Olomouc
Country
Czech Republic
Facility Name
1160.113.42004 Boehringer Ingelheim Investigational Site
City
Ostrava
Country
Czech Republic
Facility Name
1160.113.42001 Boehringer Ingelheim Investigational Site
City
Prague 5
Country
Czech Republic
Facility Name
1160.113.45001 Boehringer Ingelheim Investigational Site
City
Copenhagen
Country
Denmark
Facility Name
1160.113.45002 Boehringer Ingelheim Investigational Site
City
Odense C
Country
Denmark
Facility Name
1160.113.33004 Boehringer Ingelheim Investigational Site
City
Bron
Country
France
Facility Name
1160.113.33001 Boehringer Ingelheim Investigational Site
City
Paris cedex 18
Country
France
Facility Name
1160.113.33002 Boehringer Ingelheim Investigational Site
City
Pessac
Country
France
Facility Name
1160.113.33003 Boehringer Ingelheim Investigational Site
City
Rennes Cedex 2
Country
France
Facility Name
1160.113.49001 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1160.113.49002 Boehringer Ingelheim Investigational Site
City
Essen
Country
Germany
Facility Name
1160.113.49008 Boehringer Ingelheim Investigational Site
City
Frankfurt am Main
Country
Germany
Facility Name
1160.113.49004 Boehringer Ingelheim Investigational Site
City
Freiburg
Country
Germany
Facility Name
1160.113.49003 Boehringer Ingelheim Investigational Site
City
Heidelberg
Country
Germany
Facility Name
1160.113.49010 Boehringer Ingelheim Investigational Site
City
Witten
Country
Germany
Facility Name
1160.113.31001 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1160.113.31002 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1160.113.31004 Boehringer Ingelheim Investigational Site
City
Breda
Country
Netherlands
Facility Name
1160.113.47002 Boehringer Ingelheim Investigational Site
City
Bergen
Country
Norway
Facility Name
1160.113.47001 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1160.113.48004 Boehringer Ingelheim Investigational Site
City
Gdansk
Country
Poland
Facility Name
1160.113.48003 Boehringer Ingelheim Investigational Site
City
Warszawa
Country
Poland
Facility Name
1160.113.48001 Boehringer Ingelheim Investigational Site
City
Wroclaw
Country
Poland
Facility Name
1160.113.46004 Sahlgrenska Universitetssjukhuset
City
Göteborg
Country
Sweden
Facility Name
1160.113.46003 Skånes Universitetssjukhus Lund
City
Lund
Country
Sweden
Facility Name
1160.113.46001 Akademiska Sjukhuset
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23991661
Citation
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.113_Statement.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.113_C01952747-02.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.113_Literature.pdf
Description
Related Info

Learn more about this trial

Dabigatran Etexilate in Patients With Mechanical Heart Valves

We'll reach out to this number within 24 hrs