JPRN-UMIN000028105已完成未知
Evaluation of rivaroxaban for distal deep vein thrombosis - a single-center, randomized, open-label, assessor-blind, parallel group, exploratory study - ISE calf DVT study
Mie University Graduate School of Medicine Department of Cardiology and Nephrology0 个研究点目标入组 150 人开始时间: 2017年7月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) A patient who was allocated in this study previously 2) A patient who has already started an anticoagulant treatment including preventive medications for postoperative DVT at the orthopedic department etc. 3) A patient who has other diseases than DVT, which anticoagulants are indicated for 4) A patient who is not applicable for wearing an elastic stocking or an elastic wrap 5) A patient who has a medical history of hypersensitivity against rivaroxaban 6) A patient who has severe renal impairment [estimated creatinine clearance (CLCR) <30 ml/min: calculated from Cockcroft-Gault formula] 7) A patient with active bleeding 8) A patient who has hepatic impairment of Child-Pugh classification B and C 9) A pregnant or potentially pregnant female or a nursing female *Pregnancy shall be checked by hearing consultation. Even with a slight suspicion, the patient shall be excluded. 10) A patient who has been on a HIV protease inhibitor* 11) A patient who has been on a Cobicistat-containing product* 12) A patient who has been on an oral or injectable azole antifungal drug* 13) A patient who is suffering acute bacterial endocarditis 14) A patient who received a CNS surgery recently or has a cerebral hemorrhage which developed recently 15) A patient who has acute symptomatic PE, or acute proximal DVT with or without symptoms 16) A patient who has serious complications, of which life prognosis is considered to be <3 months 17) A patient who has uncontrolled hypertension (systolic pressure >180 mmHg or diastolic pressure >110 mmHg) 18) A patient who has participated in any clinical trials of other drugs or medical devices within 30 days prior to randomization 19) A patient who is not able to comply with series of processes related to the clinical study
研究者
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