Non-Interventional Study on Effectiveness of Elxaban Tab. in Patients With Non-valvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- major bleeding
研究概览
简要总结
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients with atrial fibrillation taking Elxaban (generic drug of apixaban) who visit hospital. The purpose is to analyze bleeding (major bleeding, minor bleeding), stroke, systemic embolism, death, other clinical events (acute myocardial infarction, pulmonary embolism, transient ischemic attack, hospitalization), drug adherence, questionnaire of life quality (AFEQT), cognitive function (KDSQ) according to the use of Elxaban.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with atrial fibrillation taking Elxaban (patients with age more than 19)
- •Patients who agree with study inclusion
排除标准
- •patients who do not agree with study inclusion
- •patients with age less than 19
- •Pregnancy, Breastfeeding
结局指标
主要结局
major bleeding
时间窗: 24 months
Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH). 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or 3. Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
death
时间窗: 24 months
Death included overall death, cardiovascular death and non-cardiovascular death.
systemic embolism
时间窗: 24 months
An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion
Stroke
时间窗: 24 months
Stroke included both ischemic and hemorrhagic stroke.
次要结局
- cognitive function (KDSQ)(24 months)
- other clinical events: acute myocardial infarction(24 months)
- other clinical events: pulmonary embolism(24 months)
- other clinical events: transient ischemic attack(24 months)
- drug adherence(24 months)
- questionnaire of life quality (AFEQT)(24 months)