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Safety and Effectiveness of Low Dose Edoxaban in Patients With NVAF

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03554837
Acronym
LEDIOS
Enrollment
2562
Registered
2018-06-13
Start date
2018-04-20
Completion date
2021-01-31
Last updated
2018-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

safety, effectiveness, low dose

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.

Interventions

None listed

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* atrial fibrillation low dose edoxaban

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
ISTH bleedingthrough study completion, an average of 1 yearISTH bleeding

Secondary

MeasureTime frameDescription
non-major bleeding eventsthrough study completion, an average of 1 yearnon-major bleeding events
Cardiovascular eventsthrough study completion, an average of 1 yeardeath, stroke, embolism, any bleeding
any side effectthrough study completion, an average of 1 yearany side effect

Countries

South Korea

Contacts

Primary ContactYoung Keun On, MD
yk.on@samsung.com82-2-3410-3420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026