A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Compared to Subcutaneous 40 mg Enoxaparin Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,055
- 试验地点
- 108
- 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
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.
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 etexilate
220 mg once daily
干预措施: Dabigatran etexilate (Drug)
Enoxaparin
40 mg once 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: 28-35 days
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, 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 Total Deep Vein Thrombosis During Treatment Period(28-35 days)
- Number of Participants With Pulmonary Embolism During Treatment Period(28-35 days)
- Number of Participants Who Died During Treatment Period(28-35 days)
- Volume of Blood Loss(Day 1)
- Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period(28-35 days)
- Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period(28-35 days)
- Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period(28-35 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(28-35 days)
- Blood Transfusion(Day 1)
- Laboratory Analyses(First administration to end of study)