PER-027-10已完成未知
RIVAROXABAN ORAL, DIRECT INHIBITOR OF XA ORAL FACTOR IN PATIENTS WITH DEEP VENOUS THROMBOSIS OR LUNG EMBOLIS SYMPTOMATIC ACIDS”
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 100（—）
入选标准
- •1. For the Einstein-DVT evaluation: Confirmed acute symptomatic PD without symptomatic PD or For Einstein-EP assessment: Acute symptomatic PD confirmed with or without symptomatic DVT. 2. FCI in writing.
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 48 hours pre-randomization treatment with therapeutic dosages of anticoagulant treatment 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) or strong CYP3A4 inducers like rifampicin.
研究者
相似试验
进行中（未招募）
不适用
Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism. - ''Einstein''Treatment and secondary prevention of venous thromboembolism in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.MedDRA version: 6.1Level: PTClassification code 10043566EUCTR2006-004495-13-ITBAYER6,260
进行中（未招募）
不适用
Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.Treatment and secondary prevention of venous thromboembolism in patients with acute symptomatic deep- vein thrombosis or pulmonary embolismEUCTR2006-004495-13-HUBayer Healthcare AG7,400
进行中（未招募）
不适用
Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.Treatment and secondary prevention of venous thromboembolism in patients with acute symptomatic deep- vein thrombosis or pulmonary embolismEUCTR2006-004495-13-ATBayer Healthcare AG7,400
进行中（未招募）
不适用
Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.Treatment and secondary prevention of venous thromboembolism in patients with acute symptomatic deep- vein thrombosis or pulmonary embolismEUCTR2006-004495-13-SEBayer Healthcare AG7,400
进行中（未招募）
不适用
Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.Treatment and secondary prevention of venous thromboembolism in patients with acute symptomatic deep- vein thrombosis or pulmonary embolismEUCTR2006-004495-13-NLBayer Healthcare AG7,400