Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE (RE-SONATE)

June 17, 2014 updated by: Boehringer Ingelheim

Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.

The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1353

Phase

  • Phase 3

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

  • Australia
    • Queensland
      • Greenslopes, Queensland, Australia
        • 1160.63.61002 Boehringer Ingelheim Investigational Site
    • South Australia
      • Elizabeth Vale, South Australia, Australia
        • 1160.63.61003 Boehringer Ingelheim Investigational Site
    • Victoria
      • Clayton, Victoria, Australia
        • 1160.63.61001 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia
        • 1160.63.61004 Boehringer Ingelheim Investigational Site
  • Austria
      • Graz, Austria
        • 1160.63.43005 Boehringer Ingelheim Investigational Site
      • Innsbruck, Austria
        • 1160.63.43006 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1160.63.43001 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1160.63.43002 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1160.63.43004 Boehringer Ingelheim Investigational Site
  • Belgium
      • Aalst, Belgium
        • 1160.63.32005 Boehringer Ingelheim Investigational Site
      • Duffel, Belgium
        • 1160.63.32004 Boehringer Ingelheim Investigational Site
      • Kortrijk, Belgium
        • 1160.63.32003 Boehringer Ingelheim Investigational Site
      • Leuven, Belgium
        • 1160.63.32001 Boehringer Ingelheim Investigational Site
      • Lier, Belgium
        • 1160.63.32002 Boehringer Ingelheim Investigational Site
  • Canada
      • Quebec, Canada
        • 1160.63.02020 Boehringer Ingelheim Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada
        • 1160.63.02013 Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • 1160.63.02004 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • 1160.63.02005 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Ceske Budejovice, Czech Republic
        • 1160.63.42004 Boehringer Ingelheim Investigational Site
      • Jablonec nad Nisou, Czech Republic
        • 1160.63.42003 Boehringer Ingelheim Investigational Site
      • Kladno, Czech Republic
        • 1160.63.42008 Boehringer Ingelheim Investigational Site
      • Liberec, Czech Republic
        • 1160.63.42012 Boehringer Ingelheim Investigational Site
      • Nymburk, Czech Republic
        • 1160.63.42010 Boehringer Ingelheim Investigational Site
      • Ostrava, Czech Republic
        • 1160.63.42009 Boehringer Ingelheim Investigational Site
      • Ostrava-Vitkovice, Czech Republic
        • 1160.63.42011 Boehringer Ingelheim Investigational Site
      • Prague 4, Czech Republic
        • 1160.63.42001 Boehringer Ingelheim Investigational Site
      • Prague 4-Krc, Czech Republic
        • 1160.63.42002 Boehringer Ingelheim Investigational Site
      • Praha 4, Czech Republic
        • 1160.63.42006 Boehringer Ingelheim Investigational Site
      • Prostejov, Czech Republic
        • 1160.63.42005 Boehringer Ingelheim Investigational Site
      • Rakovnik, Czech Republic
        • 1160.63.42007 Boehringer Ingelheim Investigational Site
      • Slany, Czech Republic
        • 1160.63.42013 Boehringer Ingelheim Investigational Site
      • Tabor, Czech Republic
        • 1160.63.42014 Boehringer Ingelheim Investigational Site
  • Estonia
      • Kohtla-Järve, Estonia
        • 1160.63.37202 Boehringer Ingelheim Investigational Site
      • Tallin, Estonia
        • 1160.63.37203 Boehringer Ingelheim Investigational Site
      • Tartu, Estonia
        • 1160.63.37201 Boehringer Ingelheim Investigational Site
  • Germany
      • Darmstadt, Germany
        • 1160.63.49013 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 1160.63.49017 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 1160.63.49018 Boehringer Ingelheim Investigational Site
      • Gießen, Germany
        • 1160.63.49014 Boehringer Ingelheim Investigational Site
      • Ludwigshafen, Germany
        • 1160.63.49011 Boehringer Ingelheim Investigational Site
      • Mannheim, Germany
        • 1160.63.49005 Boehringer Ingelheim Investigational Site
      • Mannheim, Germany
        • 1160.63.49010 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1160.63.49007 Boehringer Ingelheim Investigational Site
      • Püttlingen, Germany
        • 1160.63.49009 Boehringer Ingelheim Investigational Site
  • Italy
      • Bergamo, Italy
        • 1160.63.39006 Boehringer Ingelheim Investigational Site
      • Castelfranco Veneto (TV), Italy
        • 1160.63.39015 Boehringer Ingelheim Investigational Site
      • Chieti Scalo (CH), Italy
        • 1160.63.39019 Boehringer Ingelheim Investigational Site
      • Cosenza, Italy
        • 1160.63.39003 Boehringer Ingelheim Investigational Site
      • Fidenza (PR), Italy
        • 1160.63.39008 Boehringer Ingelheim Investigational Site
      • Firenze, Italy
        • 1160.63.39011 Boehringer Ingelheim Investigational Site
      • Genova, Italy
        • 1160.63.39009 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1160.63.39004 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1160.63.39010 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1160.63.39020 Boehringer Ingelheim Investigational Site
      • Napoli, Italy
        • 1160.63.39022 Boehringer Ingelheim Investigational Site
      • Palermo, Italy
        • 1160.63.39001 Boehringer Ingelheim Investigational Site
      • Pisa, Italy
        • 1160.63.39007 Boehringer Ingelheim Investigational Site
      • Rimini, Italy
        • 1160.63.39012 Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 1160.63.39017 Boehringer Ingelheim Investigational Site
      • Treviso, Italy
        • 1160.63.39014 Boehringer Ingelheim Investigational Site
      • Udine, Italy
        • 1160.63.39002 Boehringer Ingelheim Investigational Site
      • Vittorio veneto (TV), Italy
        • 1160.63.39016 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Gwangju-si, Korea, Republic of
        • 1160.63.82010 Boehringer Ingelheim Investigational Site
      • Incheon, Korea, Republic of
        • 1160.63.82003 Boehringer Ingelheim Investigational Site
      • Kyeonggi-do, Korea, Republic of
        • 1160.63.82005 Boehringer Ingelheim Investigational Site
      • Kyunggi-do, Korea, Republic of
        • 1160.63.82001 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1160.63.82004 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1160.63.82006 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1160.63.82008 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1160.63.82011 Boehringer Ingelheim Investigational Site
      • Suwon, Korea, Republic of
        • 1160.63.82007 Boehringer Ingelheim Investigational Site
  • Latvia
      • Daugavpils, Latvia
        • 1160.63.37101 Boehringer Ingelheim Investigational Site
      • Riga, Latvia
        • 1160.63.37102 Boehringer Ingelheim Investigational Site
  • Lithuania
      • Kaunas, Lithuania
        • 1160.63.37002 Boehringer Ingelheim Investigational Site
      • Vilnius, Lithuania
        • 1160.63.37001 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Assen, Netherlands
        • 1160.63.31010 Boehringer Ingelheim Investigational Site
      • Breda, Netherlands
        • 1160.63.31006 Boehringer Ingelheim Investigational Site
      • Den Haag, Netherlands
        • 1160.63.31007 Boehringer Ingelheim Investigational Site
      • Den Helder, Netherlands
        • 1160.63.31011 Boehringer Ingelheim Investigational Site
      • Dirksland, Netherlands
        • 1160.63.31012 Boehringer Ingelheim Investigational Site
      • Eindhoven, Netherlands
        • 1160.63.31003 Boehringer Ingelheim Investigational Site
      • Groningen, Netherlands
        • 1160.63.31001 Boehringer Ingelheim Investigational Site
      • Heerlen, Netherlands
        • 1160.63.31009 Boehringer Ingelheim Investigational Site
      • Oss, Netherlands
        • 1160.63.31008 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Christchurch, New Zealand
        • 1160.63.64002 Boehringer Ingelheim Investigational Site
  • Poland
      • Kielce, Poland
        • 1160.63.48010 Boehringer Ingelheim Investigational Site
      • Poznan, Poland
        • 1160.63.48003 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1160.63.48001 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1160.63.48002 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1160.63.48004 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1160.63.48005 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1160.63.48006 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1160.63.48007 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1160.63.48008 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Ekaterinburg, Russian Federation
        • 1160.63.07007 Boehringer Ingelheim Investigational Site
      • Kursk, Russian Federation
        • 1160.63.07004 Boehringer Ingelheim Investigational Site
      • Ufa, Russian Federation
        • 1160.63.07014 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 1160.63.07005 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 1160.63.07006 Boehringer Ingelheim Investigational Site
  • Singapore
      • Singapore, Singapore
        • 1160.63.65001 Boehringer Ingelheim Investigational Site
  • South Africa
      • Cape Town, South Africa
        • 1160.63.27003 Boehringer Ingelheim Investigational Site
      • Centurion, South Africa
        • 1160.63.27007 Boehringer Ingelheim Investigational Site
      • Krugersdorp, South Africa
        • 1160.63.27009 Boehringer Ingelheim Investigational Site
      • Somerset West, South Africa
        • 1160.63.27001 Boehringer Ingelheim Investigational Site
  • Sweden
      • Göteborg, Sweden
        • 1160.63.46001 Boehringer Ingelheim Investigational Site
      • Göteborg, Sweden
        • 1160.63.46006 Boehringer Ingelheim Investigational Site
      • Lund, Sweden
        • 1160.63.46002 Boehringer Ingelheim Investigational Site
      • Mölndal, Sweden
        • 1160.63.46004 Boehringer Ingelheim Investigational Site
      • Skövde, Sweden
        • 1160.63.46007 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 1160.63.46005 Boehringer Ingelheim Investigational Site
      • Värnamo, Sweden
        • 1160.63.46003 Boehringer Ingelheim Investigational Site
  • Switzerland
      • Basel, Switzerland
        • 1160.63.41012 Boehringer Ingelheim Investigational Site
      • Bruderholz, Switzerland
        • 1160.63.41011 Boehringer Ingelheim Investigational Site
      • Cham, Switzerland
        • 1160.63.41003 Boehringer Ingelheim Investigational Site
      • Glarus, Switzerland
        • 1160.63.41001 Boehringer Ingelheim Investigational Site
      • Luzern, Switzerland
        • 1160.63.41014 Boehringer Ingelheim Investigational Site
      • Luzern 16, Switzerland
        • 1160.63.41016 Boehringer Ingelheim Investigational Site
      • Schiers, Switzerland
        • 1160.63.41005 Boehringer Ingelheim Investigational Site
      • Thun, Switzerland
        • 1160.63.41009 Boehringer Ingelheim Investigational Site
      • Wetzikon, Switzerland
        • 1160.63.41022 Boehringer Ingelheim Investigational Site
      • Zug, Switzerland
        • 1160.63.41008 Boehringer Ingelheim Investigational Site
      • Zurich, Switzerland
        • 1160.63.41006 Boehringer Ingelheim Investigational Site
  • Thailand
      • Bangkok, Thailand
        • 1160.63.66002 Boehringer Ingelheim Investigational Site
      • Bangkok, Thailand
        • 1160.63.66003 Boehringer Ingelheim Investigational Site
      • Bangkok, Thailand
        • 1160.63.66004 Boehringer Ingelheim Investigational Site
      • Chiang Mai, Thailand
        • 1160.63.66001 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 1160.63.01025 Boehringer Ingelheim Investigational Site
      • Huntsville, Alabama, United States
        • 1160.63.01023 Boehringer Ingelheim Investigational Site
    • California
      • Laguna Hills, California, United States
        • 1160.63.01002 Boehringer Ingelheim Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • 1160.63.01014 Boehringer Ingelheim Investigational Site
    • Florida
      • Jacksonville, Florida, United States
        • 1160.63.01003 Boehringer Ingelheim Investigational Site
      • Key West, Florida, United States
        • 1160.63.01030 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Lafayette, Louisiana, United States
        • 1160.63.01022 Boehringer Ingelheim Investigational Site
      • New Iberia, Louisiana, United States
        • 1160.63.01044 Boehringer Ingelheim Investigational Site
    • Maine
      • Biddeford, Maine, United States
        • 1160.63.01017 Boehringer Ingelheim Investigational Site
    • Maryland
      • Salisbury, Maryland, United States
        • 1160.63.01004 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States
        • 1160.63.01016 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • 1160.63.01037 Boehringer Ingelheim Investigational Site
    • Montana
      • Missoula, Montana, United States
        • 1160.63.01019 Boehringer Ingelheim Investigational Site
    • Ohio
      • Columbus, Ohio, United States
        • 1160.63.01032 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Uniontown, Pennsylvania, United States
        • 1160.63.01001 Boehringer Ingelheim Investigational Site
      • Uniontown, Pennsylvania, United States
        • 1160.63.01024 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States
        • 1160.63.01005 Boehringer Ingelheim Investigational Site
      • Spartanburg, South Carolina, United States
        • 1160.63.01020 Boehringer Ingelheim Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • 1160.63.01011 Boehringer Ingelheim Investigational Site
    • Virginia
      • Richmond, Virginia, United States
        • 1160.63.01007 Boehringer Ingelheim Investigational Site
    • Washington
      • Bellevue, Washington, United States
        • 1160.63.01035 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study.
  2. Written informed consent

Exclusion criteria:

  1. Younger then 18 years of age
  2. Indication for VKA other than DVT and/or PE
  3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued
  4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
  5. Creatinine clearance < 30 ml/min
  6. Acute bacterial endocarditis
  7. Active bleeding or high risk for bleeding.
  8. Uncontrolled hypertension (investigators judgement)
  9. Intake of another experimental drug within the 30 days prior to randomization into the study
  10. Life expectancy <6 months
  11. Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dabigatran etexilate 150 mg BID
Patient to receive dabigatran etexilatate capsules 150 mg twice daily
Drug: dabigatran etexilate 150 mg twice daily (BID)
dabigatran etexilate capsules 150 mg BID
Placebo Comparator: matching placebo twice daily (BID)
Patient to receive dabigatran extexilate matching placebo capsules twice daily
Drug: matching placebo twice daily (BID)
Matching placebo BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period
Time Frame: 6 months
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period
Time Frame: 6 months
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
6 months
Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period
Time Frame: 6 months
Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.
6 months
Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
Time Frame: 6 months
Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.
6 months
Centrally Confirmed Unexplained Deaths During the Intended Treatment Period
Time Frame: 6 months
Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.
6 months
Centrally Confirmed Bleeding Event During the Treatment Period
Time Frame: 6 months

Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:

  • Fatal bleeding
  • Associated with a fall in haemoglobin of ≥2 g/dL
  • Led to the transfusion of ≥2 units packed cells or whole blood
  • Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal

Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.

Examples of these bleedings were:

  • Bleeding that compromised haemodynamics
  • Bleeding that led to hospitalisation

Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.

All bleeding events include MBEs, CRBEs, and trivial bleeding events.
6 months
Centrally Confirmed Cardiovascular Events During the Treatment Period
Time Frame: 6 months
Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.
6 months
Laboratory Measures, Especially Liver Function Tests (LFTs)
Time Frame: 6 months
Number of participants with possible clinically significant abnormalities during the treatment period.
6 months

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

November 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 13, 2007

First Submitted That Met QC Criteria

November 13, 2007

First Posted (Estimate)

November 14, 2007

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.63
  • 2007-002586-12 (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 Venous Thromboembolism

Clinical Trials on dabigatran etexilate 150 mg twice daily (BID)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe