Engel 2: REal-life aNticoaGulants Comparative bEnefit-risk in Nonvalvular Atrial fibrilLation (NVAF) in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103,101
- 试验地点
- 1
- 主要终点
- Acute Coronary Syndrome
研究概览
简要总结
The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication.
The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding, arterial thrombotic events, myocardial infarction (MI), death) between patients starting a NOAC and patients starting a VKA for NVAF in 2013
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Acute Coronary Syndrome
时间窗: One year
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Myocardial infarction (ST-segment elevation Myocardial infarction (STEMI) and non-ST-segment elevation Myocardial infarction(NSTEMI)), 2. Unstable angina.
Clinically Relevant Bleeding
时间窗: One year
First hospitalization with primary diagnosis (Tenth Revision codes of the International Classification of Diseases (ICD-10 codes)) of: 1. Hemorrhagic stroke, 2. Other critical organ or site bleeding, 3. Other bleeding (gastro-intestinal bleeding, urogenital bleeding and other bleeding subtype).
Major Bleeding
时间窗: 1 year
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Hemorrhagic stroke, 2. Other critical organ or site bleeding, 3. Other bleeding with transfusion, or acute post-hemorrhagic anemia or death during hospital stay.
Death (All-cause)
时间窗: 1 year
All-cause death (cause of death not available in the database).
Arterial Thrombotic Event
时间窗: 1 year
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Ischemic or undefined stroke, 2. Systemic arterial embolism.
Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death)
时间窗: One year
First event among clinically relevant bleeding, arterial thrombotic event, acute coronary syndrome, or death defined above.
次要结局
未报告次要终点