NCT03087487已完成不适用
Real-World Comparative Effectiveness Research and Related Economic Outcomes Among Nonvalvular Atrial Fibrillation Patients Using Oral Anti-coagulants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 466,991 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 466,991
- 试验地点
- 1
- 主要终点
- Time to first major bleeding event
研究概览
简要总结
The primary objectives of this study are to compare the risk of major bleeding and stroke/systemic embolism (SE) events among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating OAC warfarin or apixaban or dabigatran or rivaroxaban treatment.
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
- •Had 1 or more pharmacy claim for apixaban or warfarin or dabigatran or rivaroxaban during the identification period (01-Jan-2013 to 30-Sep-2015). The first OAC pharmacy claim date during the identification period will be designated as the index date
- •Patients 18 years old or older as of the index date
- •At least 1 diagnosis of atrial fibrillation prior to or on index date, identified by any medical claim
- •At least 12 months of baseline period prior to index date with continuous enrollment
排除标准
- •Evidence of valvular heart disease, transient atrial fibrillation, venous thromboembolism during the 12-month baseline period or on the index date
- •Evidence of pregnancy during the study period
- •Had a pharmacy claim for warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 12-month baseline period
- •Had more than 1 oral anticoagulant claim on the index date
结局指标
主要结局
Time to first major bleeding event
时间窗: Up to 33 months
Time to first stroke/systemic embolism (SE) event
时间窗: Up to 33 months
次要结局
- Major bleeding-related medical costs(Up to 33 months)
- Stroke/SE-related medical costs(Up to 33 months)
- All-cause Healthcare costs(Up to 33 months)
研究者
研究点 (1)
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