EUCTR2013-000619-26-AT进行中（未招募）1 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 embolismThe Einstein Choice Study - Reduced-dosed rivaroxaban in the long-term prevention of recurrent symptomatic VTE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 3,300
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 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
- •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 1650
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1650
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 cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (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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