Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey (ETAF-TR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,053
- 试验地点
- 45
- 主要终点
- Number of patients with Overt bleeding following Edoxaban therapy in routine clinical practice in Turkey
研究概览
简要总结
This is a national, multi-center, prospective study to evaluate the safety of Edoxaban in patients diagnosed with AF who are currently using Edoxaban for stroke prevention.
The primary objective:
- To evaluate safety of Edoxaban treatment in patients with atrial fibrillation (AF) on Edoxaban therapy in routine clinical practice in Turkey.
详细描述
Edoxaban was recently approved by The Turkish Medicines and Medical Devices Agency for the prevention of stroke and systemic embolism in adult patients with Nonvalvular Atrial Fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.
The study will evaluate the safety of Edoxaban in patients diagnosed with AF who are currently on Edoxaban therapy for prevention of stroke in routine clinical practice in Turkey for stroke prevention up to 1 year following treatment 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
- •Atrial fibrillation (AF) patients aged 18 years or above who are currently using Edoxaban for prevention of stroke.
- •Has provided written informed consent to participate in the study.
排除标准
- •Not on Edoxaban therapy on the date of obtaining Informed consent
- •Receiving Edoxaban therapy for an indication other than the relevant indication (stroke prevention in AF)
- •Participating in another ongoing clinical study will also be excluded.
研究组 & 干预措施
Study Group
Patients diagnosed with AF who are currently using Edoxaban for stroke prevention in Turkey.
干预措施: Edoxaban (Drug)
结局指标
主要结局
Number of patients with Overt bleeding following Edoxaban therapy in routine clinical practice in Turkey
时间窗: From baseline up to 1 year post enrollment
Overt bleeding is defined as major bleeding or clinically relevant non-major bleeding (CRNM) or any bleeding that does not meet this definition but is considered as overt bleeding by the participating physician. Rates of overt bleeding events will be presented as raw incidence rate (number of patients with events / number of patients treated) and as incidence rates per patient-year (e.g. number of patients with events per 100 patient-years).
次要结局
- Number of Patients with Clinically relevant non-major bleeding following Edoxaban therapy in routine clinical practice in Turkey(From baseline up to 1 year post enrollment)
- Number of Patients with Major bleeding following Edoxaban therapy in routine clinical practice in Turkey(From baseline up to 1 year post enrollment)
- Number of Patients with Net Clinical Benefit following Edoxaban therapy in routine clinical practice in Turkey(From baseline up to 1 year post enrollment)
- Number of Patients with Stroke, transient ischemic attack and systemic embolism following Edoxaban therapy in routine clinical practice in Turkey(From baseline up to 1 year post enrollment)
- Number of Patients with Major Cardiovascular Events Following Edoxaban Therapy in Routine Clinical Practice in Turkey(From baseline up to 1 year post enrollment)