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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:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00558259
First received: November 13, 2007
Last updated: June 17, 2014
Last verified: February 2014

November 13, 2007
June 17, 2014
November 2007
February 2011   (final data collection date for primary outcome measure)
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long term prevention of recurrent symptomatic (VTE) in patients with DVT or PE who completed 6 to 18 months of treatment with VKA
Complete list of historical versions of study NCT00558259 on ClinicalTrials.gov Archive Site
  • Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of participants with possible clinically significant abnormalities during the treatment period.
Composite of recurrent symptomatic VTE (defined PE excl unexplained death), bleeds, adverse events (AEs), laboratory measures, Acute Coronary Syndromes, EQ 5D and vital signs
Not Provided
Not Provided
 
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Venous Thromboembolism
  • Drug: dabigatran etexilate 150 mg twice daily (BID)
    dabigatran etexilate capsules 150 mg BID
  • Drug: matching placebo twice daily (BID)
    Matching placebo BID
  • Experimental: dabigatran etexilate 150 mg BID
    Patient to receive dabigatran etexilatate capsules 150 mg twice daily
    Intervention: Drug: dabigatran etexilate 150 mg twice daily (BID)
  • Placebo Comparator: matching placebo twice daily (BID)
    Patient to receive dabigatran extexilate matching placebo capsules twice daily
    Intervention: Drug: matching placebo twice daily (BID)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1353
Not Provided
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Estonia,   Germany,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Netherlands,   New Zealand,   Poland,   Russian Federation,   Singapore,   South Africa,   Sweden,   Switzerland,   Thailand
 
NCT00558259
1160.63, 2007-002586-12
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP