Safety and Effectiveness of Low Dose Edoxaban in Patients With NVAF

NCT ID: NCT03554837

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2562 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2021-01-31

Brief Summary

The efficacy and safety of edoxaban has not been adequately studied in Asians versus non-Asians, who are quite different physiologically from each other. Compared with non-East Asian patients, the East Asia patients were twice as likely to have the reasons for requiring dose reduction of edoxaban, such as CrCl 30-50 ml/min (30.0% and 18.2%, respectively), weight ≤60 kg (30.6% and 7.8%, respectively), or concomitant use of verapamil or quinidine (P-gp inhibitors, 6.6% and 3.3%, respectively). This study is aimed to evaluate the safety of the low dose edoxaban therapy in patients with high bleeding risk and non-valvular AF in the real world population of Korea.

Detailed Description

The efficacy and safety of edoxaban has not been adequately studied in Asians versus non-Asians, who are quite different physiologically from each other. Although 1,943 patients from East Asia (1,010 were from Japan, 469 from China, 234 from Taiwan, and 230 from South Korea) were included in ENGAGE AF-TIMI 48, majority of the patient (19,162) were from non-East Asia. Compared with non-East Asian patients, the East Asia patients were twice as likely to have the reasons for requiring dose reduction of edoxaban, such as CrCl 30-50 ml/min (30.0% and 18.2%, respectively), weight ≤60 kg (30.6% and 7.8%, respectively), or concomitant use of verapamil or quinidine (P-gp inhibitors, 6.6% and 3.3%, respectively). Due to the relatively small number of patients in the East Asian group included in the analysis compared with that of the patients in the non-East Asian group, a limitation preventing it from providing sufficient power for such comparison is unavoidable. This study is aimed to evaluate the safety of the low dose edoxaban therapy in patients with high bleeding risk and non-valvular AF in the real world population of Korea.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• atrial fibrillation low dose edoxaban

Exclusion Criteria

-

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Young Keun On

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young Keun On, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Young Keun On, MD

Role: CONTACT

yk.on@samsung.com

82-2-3410-3420

Facility Contacts

Young Keun On, MD

Role: primary

yk.on@samsung.com

82-2-3410-3420

MInteresa Ryu, RN

Role: backup

minteresa816@naver.com

References

Kim JY, Kim J, Park SJ, Park KM, Han SJ, Kim DK, Park YM, Lee SH, Park JS, On YK; LEDIOS Registry Investigators. Optimal Dose of Edoxaban for Very Elderly Atrial Fibrillation Patients at High Risk of Bleeding: The LEDIOS Registry. Korean Circ J. 2024 Jul;54(7):398-406. doi: 10.4070/kcj.2024.0084. Epub 2024 May 10.

Reference Type: DERIVED

PMID: 38859644 (View on PubMed)

Kim JY, Choi EK, Lim HE, Oh YS, Cho Y, On YK. Outcomes of On-Label Reduced-Dose Edoxaban in Patients With Atrial Fibrillation: The LEDIOS Registry. J Korean Med Sci. 2022 Dec 12;37(48):e335. doi: 10.3346/jkms.2022.37.e335.

Reference Type: DERIVED

PMID: 36513051 (View on PubMed)

Other Identifiers

IRB 2017-12-051

Identifier Type: -

Identifier Source: org_study_id