Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)
- Registration Number
- NCT02951039
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this non-interventional study to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) and efficacy of edoxaban use in non-preselected patients with NVAF.
- Detailed Description
Edoxaban was approved by the Ministry of Food and Drug Safety (MFDS) in Korea (date: 25th, August 2015) for the reduction in the risk of stroke and systemic embolism in patients with NVAF, treatment of deep vein thrombosis (DVT) and pulmonary embolism. Edoxaban was approved by the Taiwan Food and Drug Administration (TFDA) in Taiwan (date: 24th, February, 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 at least 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA), or treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), following 5 to 10 days of initial therapy with a parenteral anticoagulant.
Real world evidence data of routine clinical practice use of edoxaban up to two years will be collected and evaluated in approximately 2,500 patients, treated by specialized as well as non-specialized physicians in hospital centers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3008
- NVAF-patients treated with edoxaban according to Summary of Product Characteristics (SmPC).
- Written informed consent for participation in the study (ICF).
- Not simultaneously participating in any interventional study.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Edoxaban Edoxaban Patients with established NVAF treated with edoxaban according to package information. Physician's prescribing behaviour will not be influenced; patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban.
- Primary Outcome Measures
Name Time Method Rate of Participants Experiencing Real-World Safety Data Events within 2 Years within 2 years Real-world safety data events include bleeding events (including intracranial haemorrhage), adverse events and mortality
- Secondary Outcome Measures
Name Time Method Rate of Participants Compliant with Edoxaban Therapy 2 years Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown
Rate of Participants with Patient Relevant Outcomes within 2 years Patient relevant outcomes include Strokes (ischaemic and haemorrhagic) , Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), and Hospitalisations related to a cardiovascular (CV) condition.
Trial Locations
- Locations (47)
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Chungcheongnam-do, Korea, Republic of
GangNeung Asan Hospital
🇰🇷Gangneung, Gangwon-do, Korea, Republic of
Yonsei University, Wonju Severance Christian Hospital
🇰🇷Wŏnju, Gangwon-do, Korea, Republic of
Hallym University Medical Center
🇰🇷Anyang-si, Gyeonggi-do, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
National Health Insurance Service Ilsan Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Samsung Changwon Hospital
🇰🇷Changwŏn, Gyeongsangnam-do, Korea, Republic of
Scroll for more (37 remaining)Soon Chun Hyang University Hospital Cheonan🇰🇷Cheonan, Chungcheongnam-do, Korea, Republic of