EUCTR2004-002171-16-DK进行中（未招募）1 期
Once-daily oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients with acute symptomatic Deep Vein Thrombosis. The Einstein-DVT dose-finding study. - Einstein-DVT dose-finding study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Patients with confirmed acute symptomatic deep vein thrombosis i.e. proximal or extensive calf-vein thrombisis involving at least the upper third part of the calf veins, without concomitant symptomatic PE
- •- Patients who have signed an informed consent form for participation prior to study entry
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- 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 > 2X 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, acenocumarol, phenprocoumon, fluidione, UFH, enoxaparin, or tinzaparin
- •- 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
- •Prior and concomitant medication
- •Medication prior to randomization
- •Therapeutic dosages of (LMW) heparin are allowed up to a maximum of 36 hours prior to randomization. The duration of prophilactic dosages of (LWM) heparin is not restricted. A single pre-randomization starting dose of VKA is also allowed.
- •Concomitant medication
- •Non-steroid anti-inflammatory drugs (NSAIDs) and antiplatelet agents are discouraged. However if indicated, aspirin up to a dosage of 100 mg/day as well as clopidogrel (75 mg/day) are allowed. Use of 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 are not allowed
研究者
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