Edoxaban
DrugEdoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
Other names: Lixiana
NCT Number: NCT03247569
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.
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Notify Me18 year and older
All sexes
Observational
Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast, Khon Kaen, Muang District, Thailand
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
Other names: Lixiana
Time frame: 2 years
Time frame: 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
Time frame: within 2 years
Time frame: 2 years
Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
Industry
Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Thailand)
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