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.
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.
Study Type
OBSERVATIONAL
Enrollment
300
Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast
Khon Kaen, Muang District, Thailand
Bangkok Heart Hospital
Bangkok, Thailand
Bhumibol Adulyadej Hospital
Bangkok, Thailand
Bangkok Hospital Chiang Mai
Chiang Mai, Thailand
Number of participants with real world safety events
Time frame: 2 years
Number of participants with patient relevant outcomes
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: 2 years
Average duration of exposure to edoxaban
Time frame: within 2 years
Number of participants compliant with edoxaban therapy
Time frame: 2 years
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Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Thammasat University Hospital
Pathum Thani, Thailand