Once-daily oral direct factor Xa inhibitor BAY 59-7939 in patients with acute symptomatic deep-vein thrombosis to assess the dose-effect relationship and determine the optimum dose.

Bayer Australia Ltd0 个研究点目标入组 520 人开始时间: 2005年10月5日最近更新: 2020年2月10日

适应症

试验速览

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•1. 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 2. Written informed consent.

•1. 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.

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