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

Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Thailand)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03247569
Enrollment
300
Registered
2017-08-11
Start date
2017-10-18
Completion date
2022-02-28
Last updated
2022-05-06

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

Conditions

Atrial Fibrillation

Keywords

Non-valvular Atrial Fibrillation, Real World Evidence, 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 Thailand proposed this non-interventional study (NIS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other adverse events) of edoxaban use in non-preselected patients with NVAF.

Detailed description

Edoxaban was recently approved by The Thai Food and Drug Administration (Thai FDA) (date: 2nd December 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 ≥ 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 Thailand proposed this non-interventional study (NIS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other adverse events) of edoxaban use in non-preselected patients with NVAF. Real world evidence data of routine clinical practice use of edoxaban up to 2 years will be collected and evaluated in approximately 300 patients, treated by specialized as well as non-specialized physicians in hospital centres.

Interventions

DRUGEdoxaban

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

Sponsors

Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
Lead SponsorINDUSTRY

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

MeasureTime frame
Number of participants with real world safety events2 years

Secondary

MeasureTime frameDescription
Number of participants with patient relevant outcomes2 yearsCategories: 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 edoxabanwithin 2 years
Number of participants compliant with edoxaban therapy2 years

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026