Botticelli DVT study - description and results

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

Reference(s)

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

Botticelli DVT study, 2008

Treatments

Patients

Method and design

Results

Reference(s)