A Study to Evaluate Effectiveness and Safety of Edoxaban in Patients 80 Years of Age or Older With Nonvalvular Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Edoxaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Edoxaban<br>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. | Drug: Edoxaban<br>* This is observational, non-interventional study. No study drug will be administered during this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality |  | Baseline up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| Percentage of Participants With Transient Ischemic Attack, Venous Thromboembolism, and Major Cardiovascular Events |  | 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-valvular Atrial fibrillation, Elderly Patients