A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,494
- 试验地点
- 116
- 主要终点
- Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
研究概览
简要总结
The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip 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 etexilate 75 mg
daily dose 150 mg once daily, half a dose on the day of surgery
干预措施: dabigatran etexilate (Drug)
dabigatran etexilate 110 mg
daily dose 220 mg once daily, half a dose on the day of surgery
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
Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
时间窗: First administration until 31-38 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
- Death During Treatment Period(First administration until 31-38 days)
- Pulmonary Embolism During Treatment Period(First administration until 31-38 days)
- Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period(First administration until 31-38 days)
- Proximal Deep Vein Thrombosis During Treatment Period(First administration until 31-38 days)
- Total Deep Vein Thrombosis During Treatment Period(First administration until 31-38 days)
- Symptomatic Deep Vein Thrombosis During Treatment Period(First administration until 31-38 days)
- Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period(end of treatment to day 91±7)
- Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period(First administration until 31-38 days)
- Blood Transfusion(Day 1)
- Volume of Blood Loss(Day 1)
- Laboratory Analyses(First administration to end of study)