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

September 22, 2025 updated by: Daiichi Sankyo

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Daiichi Sankyo Contact for Clinical Trial Information
  • Phone Number: 908-992-6400
  • Email: CTRinfo@dsi.com

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality
Time Frame: Baseline up to 12 months
Baseline up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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])
Time Frame: Baseline up to 12 months
Baseline up to 12 months
Percentage of Participants With Stroke (Ischemic, Hemorrhagic), Systemic Embolism, Cardiovascular Mortality, and All-Cause Mortality
Time Frame: Baseline up to 12 months
Baseline up to 12 months
Number of Hospitalizations Related to Cardiovascular Conditions
Time Frame: Baseline up to 12 months
Baseline up to 12 months
Percentage of Participants With Transient Ischemic Attack, Venous Thromboembolism, and Major Cardiovascular Events
Time Frame: Baseline up to 12 months
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
Time Frame: Baseline up to 12 months
Baseline up to 12 months
Number of Participants With Bleeding Events (Major, Clinically Relevant Non-Major, Minor, and Composite)
Time Frame: Baseline up to 12 months
Baseline up to 12 months
Percentage of Participants With Edoxaban Dose Change, Based on Reason for Dose Change
Time Frame: Baseline up to 12 months
Baseline up to 12 months
Percentage of Participants Who Permanently Discontinued Edoxaban, Based on Reason for Discontinuation
Time Frame: Baseline up to 12 months
Baseline up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Daiichi Sankyo Korea Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Global Clinical Leader, Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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