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Safety and Effectiveness of Low Dose Edoxaban in Patients With NVAF — LEDIOS  

Atrial Fibrillation Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03554837
Study type Observational
Source Samsung Medical Center
Contact Young Keun On, MD
Phone 82-2-3410-3420
Email yk.on@samsung.com
Status Recruiting
Phase
Start date April 20, 2018
Completion date January 2021
View Details
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