GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III-India and Switzerland)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Stroke (hemorrhagic and ischemic, uncertain classification)
研究概览
简要总结
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events.
For administrative purposes the study is divided into three protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, 1160.136 for EU and EEA countries and 1160.171 for Switzerland. The total number of patients enrolled in three protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
Stroke (hemorrhagic and ischemic, uncertain classification)
时间窗: up to 3 years
The analysis of the outcome measure is included in study 1160.129
Myocardial infarction
时间窗: up to 3 years
The analysis of the outcome measure is included in study 1160.129
Pulmonary embolism
时间窗: up to 3 years
The analysis of the outcome measure is included in study 1160.129
Life-threatening bleeding events
时间窗: up to 3 years
The analysis of the outcome measure is included in study 1160.129
All cause death
时间窗: up to 3 years
The analysis of the outcome measure is included in study 1160.129
composite endpoint: Stroke, systemic embolism, myocardial infarction and vascular death (vascular composite endpoint)
时间窗: up to 3 years
The analysis of the outcome measure is included in study 1160.129
Transient Ischemic Attack (TIA)
时间窗: up to 3 years
The analysis of the outcome measure is included in study 1160.129
Systemic embolism
时间窗: up to 3 years
The analysis of the outcome measure is included in study 1160.129
Vascular death
时间窗: up to 3 years
The analysis of the outcome measure is included in study 1160.129
Major bleeding events (including life-threatening bleeding events)
时间窗: up to 3 years
The analysis of the outcome measure is included in study 1160.129
composite endpoint: Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death
时间窗: up to 3 years
The analysis of the outcome measure is included in study 1160.129
次要结局
未报告次要终点