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See also:

  • All venous thrombosis clinical trials
  •  

    RE-COVER study, 2009

    [NCT00291330]

    Treatments

    Studied treatment dabigatran 150 mg twice daily in a fixed-dose
    Control treatment warfarin dose-adjusted to an INR between 2.0 and 3.0

    Patients

    Patients patients with acute venous thromboembolism , treated with low molecular weight or unfractionated heparin for 5 to 11 days
    Inclusion criteria acute symptomatic uni- or bilateral deep vein thrombosis of the leg involving proximal veins, and/or pulmonary embolism confirmed by definitive objective clinical test in patients for whom at least 6 months of anticoagulant therapy is considered appropriate by the investigator
    Exclusion criteria duration of symptoms >14 days; PE with hemodynamic instability, or requiring thrombolytic therapy; another indication for warfarin; recent unstable cardiovascular disease; high risk of bleeding; liver disease, with ALT >2x ULN; estimated creatinine clearance <30 ml/min; life expectancy <6 months; requirement for >100 mg of ASA or other long-term antiplatelet therapy; contraindication to heparin or radiographic contrast material; pregnancy or risk of becoming pregnant

    Method and design

    Randomized effectives 1274 / 1265 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 6 months
    Hypothesis Non inferiority
    Primary endpoint recurrent VTE or VTE-related death


    Results

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    Major bleeding

    20 / 1274
    24 / 1265
    0,83 [0,46;1,49]

    recurrent VTE during treatment

    30 / 1274
    27 / 1265
    1,10 [0,66;1,84]

    symptomatic pulmonary embolism

    13 / 1274
    7 / 1265
    classic 1,84 [0,74;4,61]

    All cause death

    21 / 1274
    21 / 1265
    0,99 [0,55;1,81]

    Recurrent thromboembolic event

    34 / 1274
    32 / 1265
    1,05 [0,66;1,70]

    Bleeding

    207 / 1274
    280 / 1265
    0,73 [0,62;0,86]

    Symptomatic deep-vein thrombosis

    16 / 1274
    18 / 1265
    0,88 [0,45;1,72]

    Death related to venous thromboembolism

    1 / 1274
    3 / 1265
    classic 0,33 [0,03;3,18]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    Major bleeding 20 / 1274 (1,6%) 24 / 1265 (1,9%) 0,83 [0,46;1,49]  
    recurrent VTE during treatment 30 / 1274 (2,4%) 27 / 1265 (2,1%) 1,10 [0,66;1,84]  
    symptomatic pulmonary embolism 13 / 1274 (1,0%) 7 / 1265 (0,6%) 1,84 [0,74;4,61]  
    All cause death 21 / 1274 (1,6%) 21 / 1265 (1,7%) 0,99 [0,55;1,81]  
    Recurrent thromboembolic event 34 / 1274 (2,7%) 32 / 1265 (2,5%) 1,05 [0,66;1,70] at the end of follow-up 
    Bleeding 207 / 1274 (16,2%) 280 / 1265 (22,1%) 0,73 [0,62;0,86]  
    Symptomatic deep-vein thrombosis 16 / 1274 (1,3%) 18 / 1265 (1,4%) 0,88 [0,45;1,72]  
    Death related to venous thromboembolism 1 / 1274 (0,1%) 3 / 1265 (0,2%) 0,33 [0,03;3,18]  
    The primary endpoint (if exists) appears in blod characters

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Major bleeding 1,57% 1,90% -3,3‰
    recurrent VTE during treatment 2,35% 2,13% 2,2‰
    symptomatic pulmonary embolism 1,02% 5,53‰ 4,7‰
    All cause death 1,65% 1,66% -0,1‰
    Recurrent thromboembolic event 2,67% 2,53% 1,4‰
    Bleeding 16,25% 22,13% -58,9‰
    Symptomatic deep-vein thrombosis 1,26% 1,42% -1,7‰
    Death related to venous thromboembolism 0,78‰ 2,37‰ -1,6‰


    Reference(s)

    Trials register # NCT00291330
    • Schulman S, Eriksson H, Goldhaber SZ, et al. . Dabigatran etexilate versus warfarin in the treatment of venous thromboembolism. Oral presentation, . ASH Annual Meeting 2009, Abstract number 19394, 6 December 2009
      Pubmed | Hubmed | Fulltext
    • Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ. Dabigatran versus warfarin in the treatment of acute venous thromboembolism.. N Engl J Med 2009 Dec 10;361:2342-52
      Pubmed | Hubmed | Fulltext

      External links about this trial

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