Comparative Effectiveness and Safety Between Warfarin and Dabigatran Using Real World Claims Data of Japanese Non-valvular Atrial Fibrillation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22,490
- 试验地点
- 1
- 主要终点
- Incidence Rate of Stroke and Systemic Embolism (SE)
研究概览
简要总结
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.
详细描述
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •patients aged >18 year-old with confirmed diagnosis of Non-Valvular Atrial Fibrillation (NVAF) (ICD 10 code I48)
- •having a first prescription (index date) of either dabigatran or warfarin between 14 March 2011 to 30 June 2016
- •having no prescription of any Oral Anticoagulants (OACs) for 12 months prior to the index date (this period is defined as the baseline period)
排除标准
- •patients having less than 12 months of enrolment prior to the index date
- •being dialysis or kidney transplant recipients in baseline period
- •having either atrial flutter, valvular atrial fibrillation (AF)
- •mechanical valve placement, rheumatic AF
- •and/or mitral valve prolapse/regurge/stenosis in baseline period
- •having record of deep vein thrombosis or pulmonary embolism < 6 months before AF diagnosis in baseline period
研究组 & 干预措施
Atrial Fibrillation
patients with atrial fibrillation
干预措施: Warfarin (Drug)
Atrial Fibrillation
patients with atrial fibrillation
干预措施: Dabigatran (Drug)
结局指标
主要结局
Incidence Rate of Stroke and Systemic Embolism (SE)
时间窗: From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.
Incidence rate of stroke and systemic embolism (SE).
次要结局
- Incidence Rate of Major Bleeding(From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.)