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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
  •  

    MATISSE study, 2004

    Treatments

    Studied treatment fondaparinux 7.5 mg subcutaneously once daily for at least 5 days and until vitamin K antagonists induced an INR greater than 2.0.
    Control treatment enoxaparin, 1 mg/kg of body weight, subcutaneously twice daily for at least 5 days and until vitamin K antagonists induced an INR greater than 2.0.

    Patients

    Patients patients with acute symptomatic deep venous thrombosis
    Inclusion criteria >18 years of age; acute symptomatic deep venous thrombosis involving the popliteal, femoral, or iliac veins or the trifurcation of the calf veins; requiring antithrombotic therapy. Diagnostic criteria for deep venous thrombosis were a noncompressible vein found on ultrasonography or an intraluminal filling defect found on venography

    Method and design

    Randomized effectives 1098 / 1107 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 3 months
    Number of centre 154
    Geographic area international
    Hypothesis Superiority
    Primary endpoint symptomatic recurrent venous thromboembolic


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Recurrent venous thromboembolism During entire study 43 / 1098 (3,9%) 45 / 1107 (4,1%) 0,96 [0,64;1,45]
    Fatal pulmonary embolism 5 / 1098 (0,5%) 5 / 1107 (0,5%) 1,01 [0,29;3,47]
    Nonfatal pulmonary embolism 20 / 1098 (1,8%) 12 / 1107 (1,1%) 1,68 [0,83;3,42]
    Deep venous thrombosis 18 / 1098 (1,6%) 28 / 1107 (2,5%) 0,65 [0,36;1,16]
    n 1091 / 1098 (99,4%) 1101 / 1107 (99,5%) 1,00 [0,99;1,01]
    Major bleeding During initial treatment 12 / 1098 (1,1%) 13 / 1107 (1,2%) 0,93 [0,43;2,03]
    Major bleeding During entire study 28 / 1098 (2,6%) 26 / 1107 (2,3%) 1,09 [0,64;1,84]
    Clinically relevant nonmajor bleeding During initial treatment 28 / 1098 (2,6%) 33 / 1107 (3,0%) 0,86 [0,52;1,41]
    Clinically relevant nonmajor bleeding During entire study 60 / 1098 (5,5%) 63 / 1107 (5,7%) 0,96 [0,68;1,35]


    Reference(s)

    Trials register # NA
    • Büller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, Segers AE, Cariou R, Leeuwenkamp O, Lensing AW. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial.. Ann Intern Med 2004;140:867-73
      Pubmed | Hubmed | Fulltext

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