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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00558259
First Posted: November 14, 2007
Last Update Posted: June 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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).

Condition Intervention Phase
Venous Thromboembolism Drug: dabigatran etexilate 150 mg twice daily (BID) Drug: matching placebo twice daily (BID) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


  • 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.

  • Laboratory Measures, Especially Liver Function Tests (LFTs) [ Time Frame: 6 months ]
    Number of participants with possible clinically significant abnormalities during the treatment period.


Enrollment: 1353
Study Start Date: November 2007
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00558259


  Show 147 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00558259     History of Changes
Other Study ID Numbers: 1160.63
2007-002586-12 ( EudraCT Number: EudraCT )
First Submitted: November 13, 2007
First Posted: November 14, 2007
Results First Submitted: January 31, 2012
Results First Posted: March 2, 2012
Last Update Posted: June 27, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dabigatran
Antithrombins
Thrombin
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Hemostatics
Coagulants


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