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

Atrial Fibrillation Clinical Trial

— SILVERCARE_AF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804747
• Other study ID #: LIX-OS-22-01
• Status: Recruiting
• Start date: February 16, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: Daiichi Sankyo
• Contact: Daiichi Sankyo Contact for Clinical Trial Information
• Phone: 908-992-6400
• Email: CTRinfo[@]dsi.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Samsung Changwon Center	Changwon
Korea, Republic of	Dankook University Hospital	Cheonan
Korea, Republic of	Soonchunhyang University Hospital	Cheonan
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Catholic University of Korea Daejeon St. Mary's Hospital	Daejeon
Korea, Republic of	Chungnam University Hospital	Daejeon
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Goyang
Korea, Republic of	Chonnam Natinal University Hospital	Gwangju
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Chung-Ang University Hosptial	Seoul
Korea, Republic of	Ewha Womans University Seoul Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Korea Veterans Health Medical Center	Seoul
Korea, Republic of	KyungHee University Hospital at GangDong	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Catholic University of Korea St. Vincent's Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo	Daiichi Sankyo Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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