Once-daily oral direct factor Xa inhibitor BAY 59-7939 in patients with acute symptomatic deep-vein thrombosis. The Einstein-DVT dose-finding study.

Exclusion Criteria1

• Under 18 years of age.2. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT3. Other indication for VKA than DVT4. More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization5. Participation in another pharmacotherapeutic study within 30 days6. Creatinine clearance < 30 ml/min, impaired liver function (transaminases > 2 x ULN), or bacterial endocarditis7. Life expectancy <3 months8. Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin 9. Uncontrolled hypertension: systolic blood pressure >200 mmHg and diastolic blood pressure >110 mmHg10. Pregnancy or childbearing potential without proper contraceptive measures11. Any other contraindication listed in the local labeling of warfarin, acenocoumarol, phenprocoumon, fluidione, UFH, enoxaparin, or tinzaparin 12. Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazol, HIV protease inhibitors) within 4 days prior to randomization and during the study.