Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis

Inclusion Criteria: * Confirmed acute symptomatic DVT, i.e. proximal or extensive calf-vein thrombosis involving at least the upper third part of the calf veins, without concomitant symptomatic PE * Written informed consent Exclusion Criteria: * Legal lower age limitations (country specific) * Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT * Other indication for VKA than PE/DVT * More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization * Participation in another pharmacotherapeutic study within the prior 30 days * Creatinine clearance \< 30 mL/min, impaired liver function (transaminases \> 2 x ULN), or bacterial endocarditis * Life expectancy \< 3 months * Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin * Uncontrolled hypertension: systolic blood pressure \> 200 mmHg and diastolic blood pressure \> 110 mmHg * Pregnancy or childbearing potential without proper contraceptive measures * Any other contraindication listed in the labeling of warfarin, acenocoumarol, phenprocoumon, fluindione, UFH, enoxaparin, or tinzaparin * Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazole, HIV protease inhibitors) within 4 days prior to randomization and during the study