A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 264
- 主要终点
- Percentage of Subjects With Venous Thromboembolism Events
研究概览
简要总结
The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip 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 hip arthroplasty
- •Patients who are 20-84 years olds
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 30mg once daily
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
干预措施: DU-176b 30mg (Drug)
Enoxaparin sodium twice daily
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 20 mg (=2000IU) (Drug)
DU-176b 15mg once daily
DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
干预措施: DU-176b 15mg (Drug)
结局指标
主要结局
Percentage 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 Bleedings.(2 weeks)