NCT05804747

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,204 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Edoxaban	This is observational, non-interventional study. No study drug will be administered during this study.

Timeline

• Start date: 2023-02-16
• Primary completion: 2025-07-28
• Completion: 2025-07-28
• First posted: 2023-04-07
• Last updated: 2025-09-26

Locations

33 sites across 1 country: South Korea