A Phase 2b, Randomized, Double-Blind, Multi-Dose Efficacy, Safety and Dose-finding Study of the Oral Factor Xa Inhibitor DU-176b Compared With Placebo for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS J-1)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 523
- 主要终点
- Proportion of Subjects With Venous Thromboembolism Events.
研究概览
简要总结
The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral total knee arthroplasty
排除标准
- •risks of hemorrhage
- •thromboembolic risks
- •weight less than 40 kg
- •pregnant, suspect pregnancy, or subjects who want to become pregnant
研究组 & 干预措施
DU-176b 5 mg
干预措施: DU-176b (Drug)
DU-176b 15 mg
干预措施: DU-176b (Drug)
DU-176b 30 mg
干预措施: DU-176b (Drug)
DU-176b 60 mg
干预措施: DU-176b (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Subjects With Venous Thromboembolism Events.
时间窗: 2 weeks
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment. * Lower extremity DVT confirmed by bilateral venography at the end of study treatment * Definite diagnosis of symptomatic PE * Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE
次要结局
- Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding(2 weeks)