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.
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.
Study Type
OBSERVATIONAL
Enrollment
234
Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
Prince of Wales Hospital (1082)
Hong Kong, Hong Kong
Prince of Wales Hospital (1083)
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Cardiology (1801)
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Neurology (1805)
Hong Kong, Hong Kong
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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