Atrial FibrillationSILVERCARE_AFNCT05804747
A Study to Evaluate Effectiveness and Safety of Edoxaban in Patients 80 Years of Age or Older With Nonvalvular Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Daiichi Sankyo at 33 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Edoxaban
- How many people
- 1,204 participants
- Where
- 33 sitesSouth Korea
- Study dates
- 16 Feb 2023to 28 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
33 sites in 1 country.
33 sites in 1 country
South Korea33 sites
Korea University Ansan Hospital
Ansan, 15355
Dong-A University Hospital
Busan, 49201
Pusan National University Hospital
Busan, 49241
Samsung Changwon Center
Changwon, 51353
Dankook University Hospital
Cheonan, 31116
Soonchunhyang University Hospital
Cheonan, 31151
Kangwon National University Hospital
Chuncheon, 24289
Keimyung University Dongsan Medical Center
Daegu, 41931
Catholic University of Korea Daejeon St. Mary's Hospital
Daejeon, 34943
Chungnam University Hospital
Daejeon, 35015
National Health Insurance Service Ilsan Hospital
Goyang, 10444
Chosun University Hospital
Gwangju, 61453
Chonnam Natinal University Hospital
Gwangju, 61469
Wonkwang University Hospital
Iksan, 54538
Gachon University Gil Medical Center
Incheon, 21565
Gyeongsang National University Hospital
Jinju, 52727
Seoul National University Bundang Hospital
Seongnam, 13620
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Kangbuk Samsung Hospital
Seoul, 03181
Severance Hospital
Seoul, 03722
KyungHee University Hospital at GangDong
Seoul, 05278
Korea Veterans Health Medical Center
Seoul, 05368
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital
Seoul, 06273
Samsung Medical Center
Seoul, 06351
Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Chung-Ang University Hosptial
Seoul, 06973
Ewha Womans University Seoul Hospital
Seoul, 07804
Korea University Guro Hospital
Seoul, 08308
Catholic University of Korea St. Vincent's Hospital
Suwon, 16247
Ulsan University Hospital
Ulsan, 44033
Wonju Severance Christian Hospital
Wŏnju, 26426
About this study
Official 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
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Edoxaban
- Keywords
- Non-valvular Atrial fibrillation, Elderly Patients
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
This is observational, non-interventional study. No study drug will be administered during this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality
Measured: Baseline up to 12 months
Secondary outcomes (8)
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])
Measured: Baseline up to 12 months
Percentage of Participants With Stroke (Ischemic, Hemorrhagic), Systemic Embolism, Cardiovascular Mortality, and All-Cause Mortality
Measured: Baseline up to 12 months
Number of Hospitalizations Related to Cardiovascular Conditions
Measured: Baseline up to 12 months
Percentage of Participants With Transient Ischemic Attack, Venous Thromboembolism, and Major Cardiovascular Events
Measured: 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
Measured: Baseline up to 12 months
Number of Participants With Bleeding Events (Major, Clinically Relevant Non-Major, Minor, and Composite)
Measured: Baseline up to 12 months
Percentage of Participants With Edoxaban Dose Change, Based on Reason for Dose Change
Measured: Baseline up to 12 months
Percentage of Participants Who Permanently Discontinued Edoxaban, Based on Reason for Discontinuation
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start16 Feb 2023
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Korea Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804747
- Sponsor's protocol ID
- LIX-OS-22-01
- Acronym
- SILVERCARE_AF
- Status last verified
- Sep 2025
- First submitted
- 27 Mar 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05804747
- Acronym / sponsor ID
- SILVERCARE_AF / LIX-OS-22-01
- Conditions
- Atrial Fibrillation
- Keywords
- Non-valvular Atrial fibrillation, Elderly Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,204 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Korea Co., Ltd.
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edoxaban | – | Drug: EdoxabanParticipants 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. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanThis is observational, non-interventional study. No study drug will be administered during this study. | Drug | Edoxaban |
Primary outcome
Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality
Time frame: Baseline up to 12 months
8 secondary outcomes
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
Percentage of Participants With Stroke (Ischemic, Hemorrhagic), Systemic Embolism, Cardiovascular Mortality, and All-Cause Mortality
Time frame: Baseline up to 12 months
Number of Hospitalizations Related to Cardiovascular Conditions
Time frame: 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
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
Number of Participants With Bleeding Events (Major, Clinically Relevant Non-Major, Minor, and Composite)
Time frame: 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
Percentage of Participants Who Permanently Discontinued Edoxaban, Based on Reason for Discontinuation
Time frame: Baseline up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Daiichi Sankyo at 33 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality (time frame: Baseline up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.