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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Edoxaban

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.

• Study Type: Observational
• Enrollment (Actual): 1204

Contacts and Locations

Study Locations

• South Korea
  • Ansan, South Korea, 15355
    • Korea University Ansan Hospital
  • Busan, South Korea, 49201
    • Dong-A University Hospital
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Changwon, South Korea, 51353
    • Samsung Changwon Center
  • Cheonan, South Korea, 31116
    • Dankook University Hospital
  • Cheonan, South Korea, 31151
    • Soonchunhyang University Hospital
  • Chuncheon, South Korea, 24289
    • Kangwon National University Hospital
  • Daegu, South Korea, 41931
    • Keimyung University Dongsan Medical Center
  • Daejeon, South Korea, 34943
    • Catholic University of Korea Daejeon St. Mary's Hospital
  • Daejeon, South Korea, 35015
    • Chungnam University Hospital
  • Goyang, South Korea, 10444
    • National Health Insurance Service Ilsan Hospital
  • Gwangju, South Korea, 61453
    • Chosun university hospital
  • Gwangju, South Korea, 61469
    • Chonnam Natinal University Hospital
  • Iksan, South Korea, 54538
    • Wonkwang University Hospital
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Jinju, South Korea, 52727
    • Gyeongsang National University Hospital
  • Seongnam, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 07804
    • Ewha Womans University Seoul Hospital
  • Seoul, South Korea, 05278
    • Kyunghee University Hospital at Gangdong
  • Seoul, South Korea, 05368
    • Korea Veterans Health Medical Center
  • Seoul, South Korea, 06591
    • Catholic university of korea seoul st. mary's hospital
  • Seoul, South Korea, 06973
    • Chung-Ang University Hosptial
  • Suwon, South Korea, 16247
    • Catholic University of Korea St. Vincent's Hospital
  • Ulsan, South Korea, 44033
    • Ulsan University Hospital
  • Wŏnju, South Korea, 26426
    • WonJu Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants who are prescribed with edoxaban at the discretion of the physician within 8 weeks prior to enrollment. Data documentation will occur every 6 (± 90 days) and 12 months (± 90 days) from the start of edoxaban treatment. Patient visits will be conducted according to regular clinical care and should not be influenced by the foreseen data documentation time points.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Edoxaban; 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.	Drug: Edoxaban; This is observational, non-interventional study. No study drug will be administered during this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality	Baseline up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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])	Baseline up to 12 months
Percentage of Participants With Stroke (Ischemic, Hemorrhagic), Systemic Embolism, Cardiovascular Mortality, and All-Cause Mortality	Baseline up to 12 months
Number of Hospitalizations Related to Cardiovascular Conditions	Baseline up to 12 months
Percentage of Participants With Transient Ischemic Attack, Venous Thromboembolism, and Major Cardiovascular Events	Baseline up to 12 months
Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality, Based on Independent Risk Factors	Baseline up to 12 months
Number of Participants With Bleeding Events (Major, Clinically Relevant Non-Major, Minor, and Composite)	Baseline up to 12 months
Percentage of Participants With Edoxaban Dose Change, Based on Reason for Dose Change	Baseline up to 12 months
Percentage of Participants Who Permanently Discontinued Edoxaban, Based on Reason for Discontinuation	Baseline up to 12 months

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Collaborators: Daiichi Sankyo Korea Co., Ltd.
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Actual): July 28, 2025
• Study Completion (Actual): July 28, 2025

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Elderly Patients; Non-valvular Atrial fibrillation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; edoxaban
• Other Study ID Numbers: LIX-OS-22-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No