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

July 11, 2014 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

328

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium
        • 1160.113.32007 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgium
        • 1160.113.32003 Boehringer Ingelheim Investigational Site
      • Genk, Belgium
        • 1160.113.32002 Boehringer Ingelheim Investigational Site
      • Gent, Belgium
        • 1160.113.32005 Boehringer Ingelheim Investigational Site
      • Leuven, Belgium
        • 1160.113.32001 Boehringer Ingelheim Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • 1160.113.11002 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 1160.113.11006 Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • 1160.113.11001 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • 1160.113.11009 Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada
        • 1160.113.11011 Boehringer Ingelheim Investigational Site
      • Newmarket, Ontario, Canada
        • 1160.113.11012 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1160.113.11007 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Brno, Czech Republic
        • 1160.113.42002 Boehringer Ingelheim Investigational Site
      • Hradec Kralove, Czech Republic
        • 1160.113.42005 Boehringer Ingelheim Investigational Site
      • Olomouc, Czech Republic
        • 1160.113.42003 Boehringer Ingelheim Investigational Site
      • Ostrava, Czech Republic
        • 1160.113.42004 Boehringer Ingelheim Investigational Site
      • Prague 5, Czech Republic
        • 1160.113.42001 Boehringer Ingelheim Investigational Site
  • Denmark
      • Copenhagen, Denmark
        • 1160.113.45001 Boehringer Ingelheim Investigational Site
      • Odense C, Denmark
        • 1160.113.45002 Boehringer Ingelheim Investigational Site
  • France
      • Bron, France
        • 1160.113.33004 Boehringer Ingelheim Investigational Site
      • Paris cedex 18, France
        • 1160.113.33001 Boehringer Ingelheim Investigational Site
      • Pessac, France
        • 1160.113.33002 Boehringer Ingelheim Investigational Site
      • Rennes Cedex 2, France
        • 1160.113.33003 Boehringer Ingelheim Investigational Site
  • Germany
      • Dresden, Germany
        • 1160.113.49001 Boehringer Ingelheim Investigational Site
      • Essen, Germany
        • 1160.113.49002 Boehringer Ingelheim Investigational Site
      • Frankfurt am Main, Germany
        • 1160.113.49008 Boehringer Ingelheim Investigational Site
      • Freiburg, Germany
        • 1160.113.49004 Boehringer Ingelheim Investigational Site
      • Heidelberg, Germany
        • 1160.113.49003 Boehringer Ingelheim Investigational Site
      • Witten, Germany
        • 1160.113.49010 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Amsterdam, Netherlands
        • 1160.113.31001 Boehringer Ingelheim Investigational Site
      • Amsterdam, Netherlands
        • 1160.113.31002 Boehringer Ingelheim Investigational Site
      • Breda, Netherlands
        • 1160.113.31004 Boehringer Ingelheim Investigational Site
  • Norway
      • Bergen, Norway
        • 1160.113.47002 Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • 1160.113.47001 Boehringer Ingelheim Investigational Site
  • Poland
      • Gdansk, Poland
        • 1160.113.48004 Boehringer Ingelheim Investigational Site
      • Warszawa, Poland
        • 1160.113.48003 Boehringer Ingelheim Investigational Site
      • Wroclaw, Poland
        • 1160.113.48001 Boehringer Ingelheim Investigational Site
  • Sweden
      • Göteborg, Sweden
        • 1160.113.46004 Sahlgrenska Universitetssjukhuset
      • Lund, Sweden
        • 1160.113.46003 Skånes Universitetssjukhus Lund
      • Uppsala, Sweden
        • 1160.113.46001 Akademiska Sjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 1
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.
Week 2
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.
Week 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.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 1
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.
Week 2
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.
Week 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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Estimate)

August 6, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.113
  • 2010-022685-27 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Valve Diseases

Clinical Trials on dabigatran etexilate intermediate dose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe