NCT03765242已完成不适用
Retrospective Medical Chart Review Study for Atrial Fibrillation Patents Treated With Oral Anticoagulant
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 12,354 人开始时间: 2018年9月21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
- 12,354
- 试验地点
- 1
- 主要终点
- Incidence of major bleeding among oral anticoagulant (OAC) initiators
研究概览
简要总结
This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals greater than or equal to 20 years old as of the index date
- •At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records
- •Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-
- •The first warfarin or apixaban prescription date during the identification period will be designated as the index date
排除标准
- •Patient's medical records indicating pregnancy during the follow-up period
- •Patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date
- •Had > 1 OAC prescription in the patient's medical records on the index date
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Incidence of major bleeding among oral anticoagulant (OAC) initiators
时间窗: Maximum 3 years
次要结局
- Incidence of stoke/SE (secondary event) among OAC initiators(Maximum 3 years)
- Incidence of major adverse cardiac event among OAC initiators(Maximum 3 years)
- Incidence of major adverse cardiac event among OAC initiators stratified by CCr(Maximum 3 years)
- Incidence of cardiovascular/all cause death among OAC initiators(Maximum 3 years)
- Incidence of myocardial infarction among OAC initiators(Maximum 3 years)
- Incidence of myocardial infarction among OAC initiators stratified by CCr(Maximum 3 years)
- Distribution of clinical characteristics among OAC initiators(Maximum 3 years)
- Incidence of thromboembolic events(Maximum 3 years)
- Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr(Maximum 3 years)
- Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate)(Maximum 3 years)
研究者
研究点 (1)
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