A Phase III, Randomized, Parallel-group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 Followed by 150 mg Day 2-completion, and 110 mg Day 1 Followed by 220 mg Day 2-completion) of Dabigatran Etexilate Administered Orally (Capsules), Compared to Enoxaparin 30 mg Twice a Day Subcutaneous for 12 - 15 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,615
- 试验地点
- 94
- 主要终点
- Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
研究概览
简要总结
To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement 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
- Double
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dabigatran Dose 1
low dose regimen taken once daily
干预措施: Dabigatran Dose 1 - day 2 to completion (Drug)
Dabigatran Dose 1
low dose regimen taken once daily
干预措施: Dabigatran Dose 1 - day 1 (Drug)
Dabigatran Dose 2
high dose regimen taken once daily
干预措施: Dabigatran Dose 2 - day 2 to completion (Drug)
Dabigatran Dose 2
high dose regimen taken once daily
干预措施: Dabigatran Dose 2 - day 1 (Drug)
Enoxaparin
30 mg subcutaneously twice daily
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
时间窗: First administration until 12-15 days
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.
次要结局
- Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period(First administration until 12-15 days)
- Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period(First administration until 12-15 days)
- Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period(First administration until 12-15 days)
- Number of Participants With Total Deep Vein Thrombosis During Treatment Period(First administration until 12-15 days)
- Number of Participants With Pulmonary Embolism During Treatment Period(First administration until 12-15 days)
- Number of Participants Who Died During Treatment Period(First administration until 12-15 days)
- Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period(3 months)
- Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period(First administration until 12-15 days)