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

Daiichi Sankyo

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Edoxaban

Study type: Observational

Funder types: Industry

Identifiers

NCT05804747

LIX-OS-22-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,204 patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,204 participants in 1 patient group

Edoxaban

Description:

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.

Treatment:

Drug: Edoxaban