Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,980
- 试验地点
- 723
- 主要终点
- Percentage of Participants Experiencing Real-World Safety Data Events within 4 Years
研究概览
简要总结
In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non-valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this post-authorization safety study (PASS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) of edoxaban use in patients with NVAF who were not preselected.
详细描述
Patients will be from 10 different European countries and care settings (primary and secondary care and different specialties). A one-year patient recruitment period per country is planned, but it could be longer if patient recruitment numbers are not reached. Patient data will be documented at baseline (BL), one annual data documentation point during the four-year follow up (FU), and at final assessment. Patients who permanently discontinue edoxaban during the observation period will continue to be followed annually for a further two years, or until the end of the observational period (whichever comes first).
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
- •NVAF-patients treated with edoxaban according to Summary of Product Characteristics (SmPC).
- •Written informed consent for participation in the study (ICF).
- •Not simultaneously participating in any interventional study.
排除标准
- 未提供
研究组 & 干预措施
Edoxaban
Patients with established Non Valvular Atrial Fibrillation (NVAF) treated with edoxaban according to Summary of Product Characteristics (SmPC). Physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban.
干预措施: Edoxaban (Drug)
结局指标
主要结局
Percentage of Participants Experiencing Real-World Safety Data Events within 4 Years
时间窗: within 4 years
Real-world safety data events include bleeding events including intracranial haemorrhage, drug related adverse events such as liver adverse events, cardiovascular (CV) and all-cause mortality
次要结局
- Percentage of Participants with Patient Relevant Outcomes(within 4 years)
- Percentage of Participants Compliant with Edoxaban Therapy(over 4 years)