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)
Taipei Veterans General Hospital
π¨π³Taipei, Beitou District, Taiwan
Soon Chun Hyang University Hospital Cheonan
π°π·Cheonan, Chungcheongnam-do, Korea, Republic of
GangNeung Asan Hospital
π°π·Gangneung, Gangwon-do, Korea, Republic of
Yonsei University, Wonju Severance Christian Hospital
π°π·WΕnju, Gangwon-do, Korea, Republic of
Hallym University Medical Center
π°π·Anyang-si, Gyeonggi-do, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
π°π·Bucheon-si, Gyeonggi-do, Korea, Republic of
Inje University Ilsan Paik Hospital
π°π·Goyang-si, Gyeonggi-do, Korea, Republic of
National Health Insurance Service Ilsan Hospital
π°π·Goyang-si, Gyeonggi-do, Korea, Republic of
Ajou University Hospital
π°π·Suwon-si, Gyeonggi-do, Korea, Republic of
St. Carollo General Hospital
π°π·Suncheon, Jeollanam-do, Korea, Republic of
Samsung Changwon Hospital
π°π·ChangwΕn, Gyeongsangnam-do, Korea, Republic of
Gyeongsang National University Hospital
π°π·Gyeongsang, Jinju-si, Korea, Republic of
Inje Universitiy Busan Paik Hospital
π°π·Busan, Korea, Republic of
Inje University Haeundae Paik Hospital
π°π·Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
π°π·Daegu, Korea, Republic of
Yeongnam University Medical Center (1526)
π°π·Daegu, Korea, Republic of
Yeongnam University Medical Center (1533)
π°π·Daegu, Korea, Republic of
Chungnam National University Hospital
π°π·Daejeon, Korea, Republic of
Chosun University Hospital
π°π·Gwangju, Korea, Republic of
Inha University Hospital
π°π·Incheon, Korea, Republic of
Gachon University Gil Medical Center
π°π·Incheon, Korea, Republic of
Nowon Eulji Medical Center, Eulji University
π°π·Seoul, Korea, Republic of
Kyung Hee University Hospital
π°π·Seoul, Korea, Republic of
Korea University Anam Hospital
π°π·Seoul, Korea, Republic of
Seoul National University Hospital (1512)
π°π·Seoul, Korea, Republic of
Seoul National University Hospital (1534)
π°π·Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
π°π·Seoul, Korea, Republic of
Veterans Health Service Medical Center
π°π·Seoul, Korea, Republic of
Samsung Medical Center (1520)
π°π·Seoul, Korea, Republic of
Samsung Medical Center (1519)
π°π·Seoul, Korea, Republic of
Korea University Guro Hospital
π°π·Seoul, Korea, Republic of
Chang Gung Memorial Hospital, Linko
π¨π³Taoyuan, Guishan District, Taiwan
Tri-Service General Hospital
π¨π³Taipei, Neihu District, Taiwan
Chang Gung Memorial Hospital, KaoHsiung
π¨π³Kaohsiung, Niaosong District, Taiwan
National Taiwan University Hospital
π¨π³Taipei, Zhongzheng District, Taiwan
Taichung Veterans General Hospitial
π¨π³Kaohsiung, Niaosong District, Taiwan
Cheng Hsin General Hospital
π¨π³Taipei, Pai-Tou, Taiwan
KaoHsiung Veterans General Hospital
π¨π³Kaohsiung, Zuoying District, Taiwan
Chung Shan Medical University Hospitial
π¨π³Taichung, Taiwan
China Medical University Hospital
π¨π³Taichung, Taiwan
Seoul National University Bundang Hospital
π°π·Seongnam-si, Gyeonggi-do, Korea, Republic of
Dong A University Hospital
π°π·Busan, Korea, Republic of
Hanyang University Seoul Hospital
π°π·Seoul, Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
π°π·Seoul, Korea, Republic of
Hallym University, Kangnam Sacred Heart Hospital
π°π·Seoul, Korea, Republic of
Chonnam National University Hospital
π°π·Gwangju, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
π°π·Seoul, Korea, Republic of