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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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