Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (NVAF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,008
- 试验地点
- 47
- 主要终点
- Rate of Participants Experiencing Real-World Safety Data Events within 2 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 non-interventional study to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) and efficacy of edoxaban use in non-preselected patients with NVAF.
详细描述
Edoxaban was approved by the Ministry of Food and Drug Safety (MFDS) in Korea (date: 25th, August 2015) for the reduction in the risk of stroke and systemic embolism in patients with NVAF, treatment of deep vein thrombosis (DVT) and pulmonary embolism. Edoxaban was approved by the Taiwan Food and Drug Administration (TFDA) in Taiwan (date: 24th, February, 2016) for the prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age at least 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA), or treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), following 5 to 10 days of initial therapy with a parenteral anticoagulant.
Real world evidence data of routine clinical practice use of edoxaban up to two years will be collected and evaluated in approximately 2,500 patients, treated by specialized as well as non-specialized physicians in hospital centers.
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 NVAF treated with edoxaban according to package information. 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
Rate of Participants Experiencing Real-World Safety Data Events within 2 Years
时间窗: within 2 years
Real-world safety data events include bleeding events (including intracranial haemorrhage), adverse events and mortality
次要结局
- Rate of Participants Compliant with Edoxaban Therapy(2 years)
- Rate of Participants with Patient Relevant Outcomes(within 2 years)