EUCTR2006-004495-13-ES进行中（未招募）1 期
Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism. Rivaroxaban oral, inhibidor directo del factor Xa en pacientes con trombosis venosa profunda o embolia pulmonar agudas sintomáticas.
适应症
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
- •For Einstein-DVT:
- •confirmed acute symptomatic proximal DVT without symptomatic PE , or
- •For Einstein-PE:
- •confirmed acute symptomatic PE with or without symptomatic DVT
- •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
- •1. Legal lower age limitations (country specific)
- •2. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
- •3. Other indication for VKA than DVT and/or PE
- •4. More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW)Heparin/fondaparinux or more than a single dose of VKA prior to randomization
- •5. Participation in another pharmacotherapeutic study within 30 days
- •6. Creatinine clearance < 30 ml/min,
- •7. Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
- •8. Bacterial endocarditis
- •9. Life expectancy <3 months
- •10. Active bleeding or high risk for bleeding contraindicating treatment with
- •enoxaparin or VKA
- •11. Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
- •12. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding
- •13. Any other contraindication listed in the local labeling of warfarin,
- •acenocoumarol, or enoxaparin
- •14. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketokonazole)
研究者
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