A Multicenter, Prospective, Non-interventional Study to Evaluate Effectiveness and Safety of Edoxaban in Patients 80 Years of Age or Older With Nonvalvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 33
- 主要终点
- Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality
研究概览
简要总结
Non-valvular atrial fibrillation (NVAF) increases the risk of stroke by three- to five-fold, especially in elderly patients, creating a huge burden on medical system as well as a negative impact on patients' lives. Direct oral anticoagulants (DOACs) are recommended for patients with NVAF to prevent strokes. Real world data reveal the underuse of anticoagulation in the elderly, especially due to physicians' concern of bleeding, often neglecting the thromboembolic risk. This study is designed to evaluate the safety and effectiveness of edoxaban in Korean elderly patients with atrial fibrillation.
详细描述
The objective of this study will be to evaluate the safety and effectiveness of edoxaban in patients 80 years of age or older with NVAF. This observational, non-interventional study will prospectively follow Korean patients who have been prescribed edoxaban at the discretion of the physician up to 12 months.
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
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NVAF participants aged ≥ 80 years old
- •Participants who are determined to be prescribed with edoxaban at the discretion of the physician within 8 weeks prior to enrollment according to Package information
- •Participants who can return to the site in person for face-to-face visits
- •Written informed consent for participation in the study (ICF)
排除标准
- •Planning to participate or simultaneously participating in any interventional study
- •Life expectancy < 1 year
- •No influence on prescribing behavior as participants will only be included in the study after the physicians have made the clinical decision to prescribe edoxaban.
研究组 & 干预措施
Edoxaban
Participants who were prescribed edoxaban within 8 weeks of study enrollment at the discretion of the physician and were prospectively followed to assess the efficacy and safety of prescribed edoxaban.
干预措施: Edoxaban (Drug)
结局指标
主要结局
Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality
时间窗: Baseline up to 12 months
次要结局
- Number of Participants With Composite Events (Stroke, Systemic Embolism, or Cardiovascular Mortality), (Stroke, Systemic Embolism, or All-Cause Mortality), (Stroke [Ischemic, Hemorrhagic] or Systemic Embolism), and (Stroke [Ischemic, Hemorrhagic])(Baseline up to 12 months)
- Percentage of Participants With Edoxaban Dose Change, Based on Reason for Dose Change(Baseline up to 12 months)
- Percentage of Participants Who Permanently Discontinued Edoxaban, Based on Reason for Discontinuation(Baseline up to 12 months)
- Percentage of Participants With Stroke (Ischemic, Hemorrhagic), Systemic Embolism, Cardiovascular Mortality, and All-Cause Mortality(Baseline up to 12 months)
- Number of Hospitalizations Related to Cardiovascular Conditions(Baseline up to 12 months)
- Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality, Based on Independent Risk Factors(Baseline up to 12 months)
- Number of Participants With Bleeding Events (Major, Clinically Relevant Non-Major, Minor, and Composite)(Baseline up to 12 months)
- Percentage of Participants With Transient Ischemic Attack, Venous Thromboembolism, and Major Cardiovascular Events(Baseline up to 12 months)