A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS E-3 Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 716
- 主要终点
- Incidence of Subjects With Venous Thromboembolism Events.
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium 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
- •Subjects with risks of hemorrhage
- •Subjects with thromboembolic risks
- •Subjects who weigh less than 40 kg
- •Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.
研究组 & 干预措施
DU-176b
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery.
干预措施: edoxaban (Drug)
enoxaparin sodium
enoxaparin sodium 20mg (=2000IU) 0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.
干预措施: enoxaparin sodium (Drug)
结局指标
主要结局
Incidence 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 Deep Vein Thrombosis (DVT) confirmed by unilateral venography at the end of study treatment * Definite diagnosis of symptomatic Pulmonary Embolism (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 venous Thromboembolism (VTE)
次要结局
- Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.(2 weeks)