A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,867
- 试验地点
- 275
- 主要终点
- Composite of Recurrent VTE or VTE Death at 36 Months
研究概览
简要总结
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
干预措施: Dabigatran (Drug)
Warfarin (INR of 2.0-3.0)
Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily
干预措施: Warfarin (Drug)
结局指标
主要结局
Composite of Recurrent VTE or VTE Death at 36 Months
时间窗: 36 months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Composite of Recurrent VTE or VTE Death at 18 Months
时间窗: 18 months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
次要结局
- Composite of Recurrent VTE or All Cause Death at 36 Months(36 months)
- Composite of Recurrent VTE or All Cause Death at 18 Months(18 months)
- Deep Vein Thrombosis (DVT) at 36 Months(36 months)
- Deaths Related to VTE at 36 Months(36 months)
- Deaths of All Causes at 36 Months(36 months)
- Deaths of All Causes at 18 Months(18 months)
- Laboratory Analysis(18 months + 30 days follow up)
- Deaths Related to VTE at 18 Months(18 months)
- DVT at 18 Months(18 months)
- Number of Participants With Definite Acute Coronary Syndrome (ACS)(day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination)
- Symptomatic Pulmonary Embolism (PE) at 36 Months(36 months)
- Symptomatic Pulmonary Embolism (PE) at 18 Months(18 months)
- Number of Participants With Bleeding Events(first intake of study drug until 6 days following last intake of study drug)