Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 158
- 试验地点
- 30
- 主要终点
- Percentage of Patients With Any Adverse Event (AE)
研究概览
简要总结
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（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
Patient dose determined by dose allocated in 1160.113 and CrCl levels
干预措施: dabigatran etexilate low dose (Drug)
Dabigatran etexilate
Patient dose determined by dose allocated in 1160.113 and CrCl levels
干预措施: dabigatran etexilate intermediate dose (Drug)
Dabigatran etexilate
Patient dose determined by dose allocated in 1160.113 and CrCl levels
干预措施: dabigatran etexilate high dose (Drug)
warfarin
warfarin doses to maintain INR levels
干预措施: warfarin 5mg (Drug)
warfarin
warfarin doses to maintain INR levels
干预措施: warfarin 1mg (Drug)
warfarin
warfarin doses to maintain INR levels
干预措施: warfarin 3mg (Drug)
结局指标
主要结局
Percentage of Patients With Any Adverse Event (AE)
时间窗: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.
次要结局
- Percentage of Patients With Serious AEs(From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days))
- Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.(From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days))
- Percentage of Patients With AEs Leading to Discontinuation of Trial Drug(From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days))