Safety and Effectiveness of Low Dose Edoxaban in Patients With NVAF

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: atrial fibrillation low dose edoxaban Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ISTH bleeding | ISTH bleeding | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-major bleeding events | non-major bleeding events | through study completion, an average of 1 year | 
| Cardiovascular events | death, stroke, embolism, any bleeding | through study completion, an average of 1 year | 
| any side effect | any side effect | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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effectiveness, low dose, safety