Follow on Study From RE-ALIGN

July 10, 2014 updated by: Boehringer Ingelheim

Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve

To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

158

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
      • Bruxelles, Belgium
        • 1160.138.32003 Boehringer Ingelheim Investigational Site
      • Genk, Belgium
        • 1160.138.32002 Boehringer Ingelheim Investigational Site
      • Leuven, Belgium
        • 1160.138.32001 Boehringer Ingelheim Investigational Site
  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • 1160.138.11001 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • 1160.138.11009 Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada
        • 1160.138.11011 Boehringer Ingelheim Investigational Site
      • Newmarket, Ontario, Canada
        • 1160.138.11012 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1160.138.11007 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Brno, Czech Republic
        • 1160.138.42002 Boehringer Ingelheim Investigational Site
      • Olomouc, Czech Republic
        • 1160.138.42003 Boehringer Ingelheim Investigational Site
      • Ostrava, Czech Republic
        • 1160.138.42004 Boehringer Ingelheim Investigational Site
      • Prague 5, Czech Republic
        • 1160.138.42001 Boehringer Ingelheim Investigational Site
  • Denmark
      • Copenhagen, Denmark
        • 1160.138.45001 Boehringer Ingelheim Investigational Site
      • Odense C, Denmark
        • 1160.138.45002 Boehringer Ingelheim Investigational Site
  • France
      • Bron, France
        • 1160.138.33004 Boehringer Ingelheim Investigational Site
      • Paris cedex 18, France
        • 1160.138.33001 Boehringer Ingelheim Investigational Site
      • Pessac, France
        • 1160.138.33002 Boehringer Ingelheim Investigational Site
      • Rennes Cedex 2, France
        • 1160.138.33003 Boehringer Ingelheim Investigational Site
  • Germany
      • Dresden, Germany
        • 1160.138.49001 Boehringer Ingelheim Investigational Site
      • Essen, Germany
        • 1160.138.49002 Boehringer Ingelheim Investigational Site
      • Freiburg, Germany
        • 1160.138.49004 Boehringer Ingelheim Investigational Site
      • Heidelberg, Germany
        • 1160.138.49003 Boehringer Ingelheim Investigational Site
      • Witten, Germany
        • 1160.138.49010 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Amsterdam, Netherlands
        • 1160.138.31002 Boehringer Ingelheim Investigational Site
      • Breda, Netherlands
        • 1160.138.31004 Boehringer Ingelheim Investigational Site
  • Norway
      • Bergen, Norway
        • 1160.138.47002 Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • 1160.138.47001 Boehringer Ingelheim Investigational Site
  • Poland
      • Gdansk, Poland
        • 1160.138.48004 Boehringer Ingelheim Investigational Site
      • Warszawa, Poland
        • 1160.138.48003 Boehringer Ingelheim Investigational Site
      • Wroclaw, Poland
        • 1160.138.48001 Boehringer Ingelheim Investigational Site

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. Completed study 1160.113 per protocol
  2. Continuing need for anticoagulation

Exclusion criteria:

  1. uncontrolled hypertension
  2. severe renal impairment
  3. active liver disease
  4. 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: warfarin
warfarin doses to maintain INR levels
Drug: warfarin 1mg
comparator warfarin
Drug: warfarin 5mg
comparator warfarin
Drug: warfarin 3mg
comparator warfarin
Experimental: Dabigatran etexilate
Patient dose determined by dose allocated in 1160.113 and CrCl levels
Drug: dabigatran etexilate intermediate dose
active treatment (medium)
Drug: dabigatran etexilate low dose
active treatment (low)
Drug: dabigatran etexilate high dose
active treatment (high)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Any Adverse Event (AE)
Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.
From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With AEs Leading to Discontinuation of Trial Drug
Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Percentage of patients with Adverse Events leading to discontinuation of trial drug.

Prespecified clinical outcome events were not recorded as Adverse Events.
From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Percentage of Patients With Serious AEs
Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.
From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Clinical efficacy outcome events presented are:

Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis
From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

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

December 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 5, 2012

First Posted (Estimate)

January 9, 2012

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.138
  • 2011-002285-21 (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.

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