Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)
- Registration Number
- NCT03247582
- Lead Sponsor
- Daiichi Sankyo Hong Kong Ltd., a Daiichi Sankyo Company
- 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 Hong Kong proposed this non-interventional study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- 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
- Is participating in an interventional study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Edoxaban Edoxaban NVAF Patients treated with Edoxaban
- Primary Outcome Measures
Name Time Method Number of participants with real world safety events 2 years
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Prince of Wales Hospital (1083)
🇭🇰Hong Kong, Hong Kong
Prince of Wales Hospital (1082)
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital, Department of Neurology (1805)
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital, Department of Cardiology (1801)
🇭🇰Hong Kong, Hong Kong