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Completed

NCT Number: NCT05804747

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Ansan Hospital, Ansan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Edoxaban

Drug

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

Primary outcomes

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

    Time frame: Baseline up to 12 months

Secondary outcomes

  1. 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])

    Time frame: Baseline up to 12 months

  2. Percentage of Participants With Stroke (Ischemic, Hemorrhagic), Systemic Embolism, Cardiovascular Mortality, and All-Cause Mortality

    Time frame: Baseline up to 12 months

  3. Number of Hospitalizations Related to Cardiovascular Conditions

    Time frame: Baseline up to 12 months

  4. Percentage of Participants With Transient Ischemic Attack, Venous Thromboembolism, and Major Cardiovascular Events

    Time frame: Baseline up to 12 months

  5. Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality, Based on Independent Risk Factors

    Time frame: Baseline up to 12 months

  6. Number of Participants With Bleeding Events (Major, Clinically Relevant Non-Major, Minor, and Composite)

    Time frame: Baseline up to 12 months

  7. Percentage of Participants With Edoxaban Dose Change, Based on Reason for Dose Change

    Time frame: Baseline up to 12 months

  8. Percentage of Participants Who Permanently Discontinued Edoxaban, Based on Reason for Discontinuation

    Time frame: Baseline up to 12 months

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • Daiichi Sankyo Korea Co., Ltd.

Registry information

Official study title

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

Acronym: SILVERCARE_AF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2023
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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