NCT02921126已完成不适用
Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 9,914 人开始时间: 2017年4月30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
- 9,914
- 试验地点
- 1
- 主要终点
- Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy
研究概览
简要总结
To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.
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
- •are at least 18 years of age at index date
- •Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period
- •Had at least 1 claim with diagnosis of AF anytime in their records
排除标准
- •Have a record that is indicative of Valvular Atrial Fibrillation during this period
- •Have a history of the OACs prescribed during the study period as assessed during the period of data availability(i.e. history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or VKA)
- •Have more than one OAC exposure which starts on the same date
结局指标
主要结局
Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy
时间窗: Approximately 30 months
次要结局
- Distribution of patient demographics at the time of OAC initiation(at baseline)
- Composite of number and percentage of patients who are persistent with their newly prescribed OAC(Approximately 30 months)
- Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy(Approximately 30 months)
- Distribution of clinical characteristics at the time of OAC initiation(at baseline)
- Composite of number and percentage of patients with major bleeding events, thromboembolic events, or death while exposed to the newly prescribed OAC(Approximately 30 months)
研究者
研究点 (1)
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