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This trial is included in the following systematic reviews and meta-analyses:

venous thrombosis - antithrombotics - all type of patients  


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See also:

  • All venous thrombosis clinical trials
    		•  

    VanGogh DVT study, 2007

    [NCT00067093]

    Treatments

    Studied treatment subcutaneous idraparinux (2.5 mg once weekly)
    Control treatment heparin followed by an adjusted-dose vitamin K antagonist

    Patients

    Patients patients with deep-vein thrombosis
    Inclusion criteria calf trifurcation or more proximal vein that was not compressible on ultrasonography or an intraluminal filling defect on venography
    Exclusion criteria therapeutic dose of low-molecular-weight heparin or unfractionated heparin administered for more than 36 hours before randomization; thrombolysis, embolectomy, or vena cava filter required for the current episode; another indication for a vitamin K antagonist; pregnancy or breast-feeding; creatinine clearance of less than 10 ml per minute; uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg); life expectancy of less than 3 months.
    Baseline characteristics
    Age 58.4 y 
    female (%) 66 % 
    Time from onset of symptoms 8.2 days 
    cancer (%) 14.5 % 
    Immobilization (%) 6.6% 

    Method and design

    Randomized effectives 1452 / 1452 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 3 mo (6 mo)
    Hypothesis Non inferiority
    Primary endpoint 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal)


    Results

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

    Recurrent thromboembolic event

    42 / 1452
         43 / 1452
         0,98 [0,64;1,48]

    Bleeding

    65 / 1452
         101 / 1452
         0,64 [0,48;0,87]

    All cause death

    33 / 1452
         32 / 1452
         1,03 [0,64;1,67]

    Major bleeding

    12 / 1452
         17 / 1452
         0,71 [0,34;1,47]

    recurrent VTE during treatment

    42 / 1452
         43 / 1452
         0,98 [0,64;1,48]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    Recurrent thromboembolic event 42 / 1452 (2,9%) 43 / 1452 (3,0%) 0,98 [0,64;1,48] at day 92 
    Bleeding 65 / 1452 (4,5%) 101 / 1452 (7,0%) 0,64 [0,48;0,87] any clinically relevant bleeding at day 92 
    Major bleeding 12 / 1452 (0,8%) 17 / 1452 (1,2%) 0,71 [0,34;1,47] at day 92 
    recurrent VTE during treatment 42 / 1452 (2,9%) 43 / 1452 (3,0%) 0,98 [0,64;1,48] at day 92 
    All cause death 33 / 1452 (2,3%) 32 / 1452 (2,2%) 1,03 [0,64;1,67] at day 92 
    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.
    Recurrent thromboembolic event 2,89% 2,96% -0,7‰
    Bleeding 4,48% 6,96% -24,8‰
    Major bleeding 8,26‰ 1,17% -3,4‰
    recurrent VTE during treatment 2,89% 2,96% -0,7‰
    All cause death 2,27% 2,20% 0,7‰


    Reference(s)

    Trials register # NCT00067093
    • Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. . N Engl J Med 2007 Sep 13;357:1094-104
      Pubmed | Hubmed | Fulltext

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