Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,353
- 试验地点
- 147
- 主要终点
- Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period
研究概览
简要总结
The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).
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 150 mg BID
Patient to receive dabigatran etexilatate capsules 150 mg twice daily
干预措施: dabigatran etexilate 150 mg twice daily (BID) (Drug)
matching placebo twice daily (BID)
Patient to receive dabigatran extexilate matching placebo capsules twice daily
干预措施: matching placebo twice daily (BID) (Drug)
结局指标
主要结局
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period
时间窗: 6 months
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
次要结局
- Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period(6 months)
- Centrally Confirmed Unexplained Deaths During the Intended Treatment Period(6 months)
- Laboratory Measures, Especially Liver Function Tests (LFTs)(6 months)
- Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period(6 months)
- Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period(6 months)
- Centrally Confirmed Bleeding Event During the Treatment Period(6 months)
- Centrally Confirmed Cardiovascular Events During the Treatment Period(6 months)