Atrial Fibrillation
Conditions
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
Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
Sponsors
Study design
Eligibility
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
Thailand