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

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ClinicalTrials.gov Identifier: NCT00558259
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : March 2, 2012
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Venous Thromboembolism Drug: dabigatran etexilate 150 mg twice daily (BID) Drug: matching placebo twice daily (BID) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1353 participants
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.
Study Start Date : November 2007
Actual Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00558259    
Other Study ID Numbers: 1160.63
2007-002586-12 ( EudraCT Number: EudraCT )
First Posted: November 14, 2007    Key Record Dates
Results First Posted: March 2, 2012
Last Update Posted: June 27, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dabigatran
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants