EUCTR2006-004494-96-FR进行中（未招募）1 期
Once-daily oral direct factor Xa inhibitor rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension study. - The Einstein-Extension Study
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
- 性别
- All
入选标准
- •1. Patients with confirmed symptomatic PE or DVT who have been treated for 6 or
- •12 months with VKA (either warfarin or acenocoumarol ) or rivaroxaban
- •2. Written informed consent
- •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. Indication for VKA other than DVT and/or PE
- •3. Patients in whom anticoagulant treatment for their index PE or DVT should be
- •4. Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis)
- •or ALAT > 3 x ULN
- •5. Creatinine clearance < 30 ml/min
- •6. Bacterial endocarditis
- •7. Active bleeding or high risk for bleeding.
- •8. Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
- •9. Childbearing potential without proper contraceptive measures, pregnancy or
- •breast feeding
- •10. Participation in another pharmacotherapeutic study other than the Einstein VTE
- •program (rivaroxaban/11702) within the prior 30 days
- •11. Life expectancy <3 months
- •12. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors,
- •systemic ketoconazole)
研究者
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已完成
3 期
Once-daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. The Einstein-Extension StudyCTRI/2007/091/000026Bayer HealthCare AG1,300
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