CompletedNot Applicable

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

South Korea1,204 participantsStarted 2023-02-16

Plain-language 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.

Who can participate

Age range80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Baseline up to 12 months

Trial details

NCT IDNCT05804747

SponsorDaiichi Sankyo

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-07-28