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See also:

  • All venous thrombosis clinical trials

    Botticelli DVT study, 2008



    Studied treatment apixaban 5 mg twice-daily, 10 mg twice-daily, or 20 mg once-daily for 84-91 days
    Control treatment low molecular weight heparin followed by vitamin K antagonists


    Patients patients with symptomatic deep vein thrombosis
    Inclusion criteria symptomatic proximal DVT or extensive calf vein thrombosis, involving at least the upper third of the deep calf veins (trifurcation area) confirmed by compression ultrasonography (CUS) or venography
    Exclusion criteria symptomatic pulmonary embolism; creatinine clearance below 30 mL/min;impaired liver function; caval filter, fibrinolytic agent for the current episode; indications for VKAs other than DVT; more than 24 h of prerandomization treatment with therapeutic doses of unfractionated heparin, LMWH or fondaparinux or more than a single starting dose of VKA prior to randomization; active bleeding or high risk for bleeding contraindicating treatment with LMWH, fondaparinux or VKA; systolic blood pressure higher than 200 mmHg or diastolic blood pressure higher than 110 mmHg; more than 165 mg of acetylsalicylic acid/day; childbearing potential without adequate contraception; pregnancy; breast-feeding; any other contraindication listed in the local labeling of enoxaparin, tinzaparin fondaparinux, warfarin, acenocoumarol, or phenprocoumon

    Method and design

    Randomized effectives 358 / 118 (studied vs. control)
    Design Parallel groups
    Blinding open
    Hypothesis Superiority
    Primary endpoint recurrent VTE or asymptomatic deterioration in the
    Remarks dose-ranging study; the primary efficacy endpoint was the composite of symptomatic recurrent venous thromboembolism and asymptomatic deterioration of bilateral compression ultrasound or perfusion lung scan


    No results available for this trial - no clinical endpoint reported


    Trials register # NCT00252005
    • Buller H, Deitchman D, Prins M, Segers A. Efficacy and safety of the oral direct factor Xa inhibitor apixaban for symptomatic deep vein thrombosis. The Botticelli DVT dose-ranging study.. J Thromb Haemost 2008 Aug;6:1313-8
      Pubmed | Hubmed | Fulltext

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