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

Daiichi Sankyo1,204 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,204

Conditions

Atrial Fibrillation

Interventions

EdoxabanDRUG

This is observational, non-interventional study. No study drug will be administered during this study.

Eligibility

Sex: ALLMin age: 80 Years

Medical Language ↔ Plain English

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.

Locations (33)

Korea University Ansan Hospital

Ansan, South Korea

Dong-A University Hospital

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Samsung Changwon Center

Changwon, South Korea

Dankook University Hospital

Cheonan, South Korea

Soonchunhyang University Hospital

Outcomes

Primary Outcomes

Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality