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Completed

NCT Number: NCT00558259

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

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).

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1160.63.61002 Boehringer Ingelheim Investigational Site, Greenslopes, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Written informed consent

Exclusion criteria

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

Treatment and study plan

dabigatran etexilate 150 mg twice daily (BID)

Drug

dabigatran etexilate capsules 150 mg BID

matching placebo twice daily (BID)

Drug

Matching placebo BID

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Acronym: RE-SONATE

Important dates

Study start
2007
Primary completion
2011
First posted
Nov 14, 2007
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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