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

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05804747

Collaborator

Daiichi Sankyo Korea Co., Ltd. (Industry)

1,100

Enrollment

Locations

33.5

Anticipated Duration (Months)

36.7

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Edoxaban

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

Study Type:

Observational

Anticipated Enrollment :

1100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Feb 16, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality [Baseline up to 12 months]

Secondary Outcome Measures

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]
Number of Participants With Bleeding Events (Major, Clinically Relevant Non-Major, Minor, and Composite) [Baseline up to 12 months]
Percentage of Participants With Edoxaban Dose Change, Based on Reason for Dose Change [Baseline up to 12 months]
Percentage of Participants Who Permanently Discontinued Edoxaban, Based on Reason for Discontinuation [Baseline up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

80 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Korea University Ansan Hospital	Ansan	Korea, Republic of	15355
2	Dong-A University Hospital	Busan	Korea, Republic of	49201
3	Pusan National University Hospital	Busan	Korea, Republic of	49241
4	Samsung Changwon Center	Changwon	Korea, Republic of	51353
5	Dankook University Hospital	Cheonan	Korea, Republic of	31116
6	Soonchunhyang University Hospital	Cheonan	Korea, Republic of	31151
7	Kangwon National University Hospital	Chuncheon	Korea, Republic of	24289
8	Keimyung University Dongsan Medical Center	Daegu	Korea, Republic of	41931
9	Catholic University of Korea Daejeon St. Mary's Hospital	Daejeon	Korea, Republic of	34943
10	National Health Insurance Service Ilsan Hospital	Goyang	Korea, Republic of	10444
11	Chosun University Hospital	Gwangju	Korea, Republic of	61453
12	Chonnam Natinal University Hospital	Gwangju	Korea, Republic of	61469
13	Wonkwang University Hospital	Iksan	Korea, Republic of	54538
14	Gachon University Gil Medical Center	Incheon	Korea, Republic of	21565
15	Gyeongsang National University Hospital	Jinju	Korea, Republic of	52727
16	Seoul National University Bundang Hospital	Seongnam	Korea, Republic of	13620
17	Korea University Anam Hospital	Seoul	Korea, Republic of	02841
18	Seoul National University Hospital	Seoul	Korea, Republic of	03080
19	Kangbuk Samsung Hospital	Seoul	Korea, Republic of	03181
20	Severance Hospital	Seoul	Korea, Republic of	03722
21	KyungHee University Hospital at GangDong	Seoul	Korea, Republic of	05278
22	Asan Medical Center	Seoul	Korea, Republic of	05505
23	Gangnam Severance Hospital	Seoul	Korea, Republic of	06273
24	Samsung Medial Center	Seoul	Korea, Republic of	06351
25	Catholic University of Korea Seoul St. Mary's Hospital	Seoul	Korea, Republic of	06591
26	Chung-Ang University Hosptial	Seoul	Korea, Republic of	06973
27	Korea University Guro Hospital	Seoul	Korea, Republic of	08308
28	Catholic University of Korea St. Vincent's Hospital	Suwon	Korea, Republic of	16247
29	Ulsan University Hospital	Ulsan	Korea, Republic of	44033
30	Wonju Severance Christian Hospital	Wŏnju	Korea, Republic of	26426

Sponsors and Collaborators

Daiichi Sankyo, Inc.
Daiichi Sankyo Korea Co., Ltd.

Investigators

Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daiichi Sankyo, Inc.

ClinicalTrials.gov Identifier:

NCT05804747

Other Study ID Numbers:

LIX-OS-22-01

First Posted:

Apr 7, 2023

Last Update Posted:

Apr 10, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Daiichi Sankyo, Inc.

Non-valvular Atrial fibrillation

Elderly Patients

Additional relevant MeSH terms:

Atrial Fibrillation

Edoxaban

Study Results

No Results Posted as of Apr 10, 2023