Safety and Effectiveness of Low Dose Edoxaban in Patients With NVAF

Atrial Fibrillation Clinical Trial

— LEDIOS  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03554837
• Other study ID #: IRB 2017-12-051
• Status: Recruiting
• Start date: April 20, 2018
• Est. completion date: January 2021

Study information

• Verified date: June 2018
• Source: Samsung Medical Center
• Contact: Young Keun On, MD
• Phone: 82-2-3410-3420
• Email: yk.on[@]samsung.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2562
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• atrial fibrillation low dose edoxaban

Exclusion Criteria:

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ISTH bleeding	ISTH bleeding	through study completion, an average of 1 year
Secondary	non-major bleeding events	non-major bleeding events	through study completion, an average of 1 year
Secondary	Cardiovascular events	death, stroke, embolism, any bleeding	through study completion, an average of 1 year
Secondary	any side effect	any side effect	through study completion, an average of 1 year