NCT02951039

Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)

Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (NVAF)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,008 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this non-interventional study to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) and efficacy of edoxaban use in non-preselected patients with NVAF.

Detailed description

Edoxaban was approved by the Ministry of Food and Drug Safety (MFDS) in Korea (date: 25th, August 2015) for the reduction in the risk of stroke and systemic embolism in patients with NVAF, treatment of deep vein thrombosis (DVT) and pulmonary embolism. Edoxaban was approved by the Taiwan Food and Drug Administration (TFDA) in Taiwan (date: 24th, February, 2016) for the prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age at least 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA), or treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), following 5 to 10 days of initial therapy with a parenteral anticoagulant. Real world evidence data of routine clinical practice use of edoxaban up to two years will be collected and evaluated in approximately 2,500 patients, treated by specialized as well as non-specialized physicians in hospital centers.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Edoxaban	Prescribed according to approved label

Timeline

• Start date: 2017-02-21
• Primary completion: 2020-10-15
• Completion: 2020-10-15
• First posted: 2016-11-01
• Last updated: 2021-01-12

Locations

47 sites across 2 countries: South Korea, Taiwan