Safety and Effectiveness of Low Dose Edoxaban in Patients With NVAF
LEDIOS
A Multicenter, Prospective, Non-interventional, Cohort Study to Evaluate the Safety and Effectiveness of Low Dose Edoxaban in Patients With Non-valvular Atrial Fibrillation (NVAF), Who Are Applicable to Any of the Dose Reduction Criteria
1 other identifier
observational
2,562
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2018
CompletedStudy Start
First participant enrolled
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedJune 13, 2018
June 1, 2018
2.6 years
April 19, 2018
June 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ISTH bleeding
ISTH bleeding
through study completion, an average of 1 year
Secondary Outcomes (3)
non-major bleeding events
through study completion, an average of 1 year
Cardiovascular events
through study completion, an average of 1 year
any side effect
through study completion, an average of 1 year
Eligibility Criteria
AF patients who are taking low dose edoxaban
You may qualify if:
- atrial fibrillation low dose edoxaban
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (2)
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.
PMID: 38859644DERIVEDKim 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.
PMID: 36513051DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Keun On, MD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 19, 2018
First Posted
June 13, 2018
Study Start
April 20, 2018
Primary Completion
December 1, 2020
Study Completion
January 1, 2021
Last Updated
June 13, 2018
Record last verified: 2018-06