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

NCT ID: NCT05804747

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-16

Study Completion Date

2025-07-28

Brief Summary

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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

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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

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Edoxaban

Intervention Type DRUG

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

Interventions

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Edoxaban

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Korea Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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Korea University Ansan Hospital

Ansan, , South Korea

Site Status

Dong-A University Hospital

Busan, , South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Samsung Changwon Center

Changwon, , South Korea

Site Status

Dankook University Hospital

Cheonan, , South Korea

Site Status

Soonchunhyang University Hospital

Cheonan, , South Korea

Site Status

Kangwon National University Hospital

Chuncheon, , South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Catholic University of Korea Daejeon St. Mary's Hospital

Daejeon, , South Korea

Site Status

Chungnam University Hospital

Daejeon, , South Korea

Site Status

National Health Insurance Service Ilsan Hospital

Goyang, , South Korea

Site Status

Chosun University Hospital

Gwangju, , South Korea

Site Status

Chonnam Natinal University Hospital

Gwangju, , South Korea

Site Status

Wonkwang University Hospital

Iksan, , South Korea

Site Status

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Gyeongsang National University Hospital

Jinju, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

KyungHee University Hospital at GangDong

Seoul, , South Korea

Site Status

Korea Veterans Health Medical Center

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Chung-Ang University Hosptial

Seoul, , South Korea

Site Status

Ewha Womans University Seoul Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Catholic University of Korea St. Vincent's Hospital

Suwon, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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LIX-OS-22-01

Identifier Type: -

Identifier Source: org_study_id

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