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

NCT05804747 | Completed

• 1 other identifier: LIX-OS-22-01
• Study Type: observational
• Target: 1,204
• Locations: 1 country
• Sites: 33

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Non-valvular Atrial fibrillation; Elderly Patients

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality

  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])

  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

Study Arms (1)

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

Interventions

Edoxaban DRUG

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

Edoxaban

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Daiichi Sankyo Korea Co., Ltd.: collaborator

Study Sites (33)

Korea University Ansan Hospital

Ansan, 15355, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Samsung Changwon Center

Changwon, 51353, South Korea

Location

Dankook University Hospital

Cheonan, 31116, South Korea

Location

Soonchunhyang University Hospital

Cheonan, 31151, South Korea

Location

Kangwon National University Hospital

Chuncheon, 24289, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Catholic University of Korea Daejeon St. Mary's Hospital

Daejeon, 34943, South Korea

Location

Chungnam University Hospital

Daejeon, 35015, South Korea

Location

National Health Insurance Service Ilsan Hospital

Goyang, 10444, South Korea

Location

Chosun University Hospital

Gwangju, 61453, South Korea

Location

Chonnam Natinal University Hospital

Gwangju, 61469, South Korea

Location

Wonkwang University Hospital

Iksan, 54538, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Gyeongsang National University Hospital

Jinju, 52727, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

KyungHee University Hospital at GangDong

Seoul, 05278, South Korea

Location

Korea Veterans Health Medical Center

Seoul, 05368, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Chung-Ang University Hosptial

Seoul, 06973, South Korea

Location

Ewha Womans University Seoul Hospital

Seoul, 07804, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Catholic University of Korea St. Vincent's Hospital

Suwon, 16247, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: February 16, 2023
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (33)