A Phase 3, Randomized, Open Label, Safety and Efficacy Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (STARS J-4 Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- The Incidence of Major or Clinically Relevant Non-major Bleeding
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)
排除标准
- •Subjects with risks of hemorrhage
- •Subjects with thrombolic 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: DU-176b (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 20mg (Drug)
结局指标
主要结局
The Incidence of Major or Clinically Relevant Non-major Bleeding
时间窗: 2 weeks
Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.
次要结局
- Proportion of Subjects With Venous Thromboembolism Events.(2 weeks)