NL-OMON41605已完成3 期
Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus ASA in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism The Einstein Choice Study - The Einstein Choice-study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 200
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 99（—）
入选标准
- •1. Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week
- •2. Written informed consent
排除标准
- •1. Legal lower age limitations (country specific)
- •2. Indication for therapeutic-dosed anticoagulants
- •3. Hypersensitivity to investigational or comparator treatment
- •4. Any other contraindication listed in the local labeling for investigational or comparator treatment
- •5. Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID)
- •6. Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- •7. Calculated creatinine clearance <30 mL/min
- •8. Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
- •9. Life expectancy <6 months
- •10. Concomitant use of strong inhibitors of both CYP3A4 and P-gp, i.e. all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
- •11. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding
- •12. Participation in a study with an investigational drug or medical device within 30 days prior to randomization
研究者
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