A Phase IV, Open-Label, Multi-center Study to Evaluate the Safety of Apixaban in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 557
- 试验地点
- 1
- 主要终点
- Number of Participants With Composite of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding/Clinically Relevant Non-major Bleeding (CRNM) While Undergoing Elective TKR or THR at the End of Treatment + 2 Days
研究概览
简要总结
The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip replacement
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Subjects undergoing elective total knee or hip replacement or a revision of at least one component of a total knee or hip replacement
排除标准
- •Women who are pregnant or breastfeeding
- •Known or suspected, acquired or bleeding or coagulation disorder in the subject or a first degree relative
- •Active bleeding or at high risk for bleeding.
- •Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days other than the elective knee/hip surgery
- •Active hepatobiliary disease
- •Hemoglobin <9 g/dL
- •Platelet count <100,000/mm3
- •Creatinine clearance <30 mL/min
研究组 & 干预措施
Apixaban (2.5 mg)
Apixaban 2.5 mg tablets by mouth twice daily, 12 days for TKR subjects or 35 days for THR subjects
干预措施: Apixaban (Drug)
结局指标
主要结局
Number of Participants With Composite of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding/Clinically Relevant Non-major Bleeding (CRNM) While Undergoing Elective TKR or THR at the End of Treatment + 2 Days
时间窗: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR
TKR = Total knee replacement; THR = Total hip replacement. ISTH major bleeding is 1) Fatal or 2) Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or 3) Bleeding that results in a fall of hemoglobin of 2 g/dL or more or transfusion of 2 units or more of packed red cells or whole blood within 24 hours. CRNM bleeding is bleeding that 1) Is clinically acute and overt 2) Does not satisfy criteria as a major bleed but requires medical intervention, such as a visit to a physician's office, emergency room, or urgent care center for epistaxis
次要结局
- Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days(2 weeks + 2 days for TKR, 5 weeks + 2 days for THR)