跳至主要内容
临床试验/NCT00831714
NCT00831714已完成不适用

Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery of Hip or Knee

Bayer0 个研究点目标入组 19,076 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
19,076
主要终点
Data collection on: Bleeding events reported as serious or non-serious adverse events; Symptomatic thromboembolic events (DVT, PE) reported as adverse events; Uncommon adverse events (incidence rate between 0.1 % and 1 %); All cause mortality

研究概览

简要总结

The main goal is to provide additional information to the risk-benefit assessment of the drug.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Female and male patients who will undergo elective hip or knee arthroplasty.

排除标准

  • Exclusion criteria must be read in conjunction with the local product information.

研究组 & 干预措施

Group 1

干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)

Group 2

干预措施: Standard care treatment for VTE prophylaxis (Drug)

结局指标

主要结局

Data collection on: Bleeding events reported as serious or non-serious adverse events; Symptomatic thromboembolic events (DVT, PE) reported as adverse events; Uncommon adverse events (incidence rate between 0.1 % and 1 %); All cause mortality

时间窗: During observation period of three months

次要结局

未报告次要终点

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

相似试验

Xarelto for VTE Prophylaxis After Hip or Knee... | 临床试验