Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)

Conditions

Atrial Fibrillation

Keywords

Real World Evidence, Non-valvular Atrial Fibrillation, Observational Safety

Brief summary

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Hong Kong proposed this non-interventional study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.

Detailed description

Edoxaban was approved by the Pharmacy and Poisons Board in Hong Kong (date: 31 May 2016) for the: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo proposed this non-interventional study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with NVAF. Real world evidence from routine clinical practice using edoxaban up to 2 years will be collected and evaluated in approximately 200 patients, treated by specialized as well as non-specialized physicians in hospital centers.

Giuseppe Boriani, Paulus Kirchhof, José Souza, Jan Steffel, Yukihiro Koretsune et al. (11 authors)

European Journal of Preventive Cardiology2025-10-18

10.1093/eurjpc/zwaf685

Edoxaban treatment in routine clinical practice is highly concordant with the 2020 European Society of Cardiology atrial fibrillation guidelines: results from the noninterventional Global ETNA-AF programme

Doralisa Morrone, Leon Dinshaw, José Souza, Cathy Chen, Paulus Kirchhof et al. (11 authors)

European Heart Journal Open2025-03-01

10.1093/ehjopen/oeaf004

Two‐Year Follow‐Up of Patients With Atrial Fibrillation Receiving Edoxaban in Routine Clinical Practice: Results From the Global ETNA‐AF Program

Raffaele De Caterina, Martin Unverdorben, Cathy Chen, Eue‐Keun Choi, Yukihiro Koretsune et al. (11 authors)

Clinical Cardiology2025-02-273 citations

10.1002/clc.70091

Impact of body weight and body mass index on clinical outcomes of edoxaban therapy in atrial fibrillation patients included in the ETNA-AF-Global registry

Giuseppe Boriani, Júlio Souza, Jan Steffel, Yukihiro Koretsune, Tze‐Fan Chao et al. (10 authors)

European Heart Journal2024-10-01

10.1093/eurheartj/ehae666.604

Interventions

DRUGEdoxaban

Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Is a NVAF-patient whose physician has made the clinical decision to prescribe edoxaban therapy according to Package Information * Has provided written informed consent to participate in the study

Exclusion criteria

* Is participating in an interventional study

Design outcomes

Primary

Measure	Time frame
Number of participants with real world safety events	2 years

Secondary

Measure	Time frame	Description
Number of participants with patient relevant outcomes	2 years	Categories: Strokes (ischaemic and haemorrhagic), Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), Hospitalisations related to cardiovascular (CV) condition
Average duration of exposure to edoxaban	within 2 years	—
Number of participants compliant with edoxaban therapy	2 years	—

Countries

Hong Kong

Outcome results

None listed