Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 411
- 试验地点
- 35
- 主要终点
- Major bleeding.
研究概览
简要总结
The aim of the present study is to prospectively evaluate the safety of Edoxaban.
详细描述
The aim of the present study is to prospectively evaluate the safety of Edoxaban in daily clinical practice in Spain in elderly patients with nonvalvular atrial fibrillation who meet the criteria for frailty and who have been prescribed the drug recently (<6 months prior to inclusion).
The study will provide us with a clear and real-life picture of bleeding and ischemic complications and possible treatment interruptions with Edoxaban in real life and in a large subgroup, although underrepresented in the studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 75 years of age or older with a diagnosis of NVAF.
- •Patients in whom treatment had been started in the 6 months prior to enrollment in the study with Edoxaban for prevention of stroke and systemic embolism after diagnosis of NVAF and according to the drug's technical data sheet.
- •Frailty criteria according to the FRAIL scale (score of 3 to 5 points).
- •Written informed consent to participate in the study prior to any intervention.
排除标准
- •Creatinine clearance according to the CKD-EPI formula less than 15 ml/min/m2
- •Moderate or severe hepatic insufficiency (Defined as grade B or C of the Child-Pugh classification.
- •Contraindication to receive Edoxaban according to the Technical Data Sheet.
- •Participation in any clinical drug trial in the 2 months prior to the initial visit.
- •Absence of recorded patient or treatment information.
- •Surgical or percutaneous occlusion of the left atrial appendage or intention to perform such intervention at the time of inclusion.
- •Any circumstance that, in the opinion of the investigator, affects patient follow-up (including life expectancy of less than two years or inability to perform follow-up).
- •Persons who are legally incapacitated or unable to understand informed consent.
研究组 & 干预措施
Patients
Elderly patients diagnosed with nonvalvular atrial fibrillation who meet the frailty criteria and who had been receiving anticoagulant treatment with Edoxaban for no more than 6 months prior to inclusion in the study.
干预措施: Edoxaban (Drug)
结局指标
主要结局
Major bleeding.
时间窗: 12 months
Proportion of patients who had a major bleeding during the 12 months of follow-up.
次要结局
- Stroke or systemic embolism.(12 months)