Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)
January 11, 2021 updated by: Daiichi Sankyo, Inc.
Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (NVAF)
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
3008
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Busan, Korea, Republic of, 48108
- Inje university Haeundae Paik Hospital
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Busan, Korea, Republic of, 47392
- Inje Universitiy Busan Paik Hospital
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Busan, Korea, Republic of, 49201
- Dong A University Hospital
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Daegu, Korea, Republic of, 41931
- Keimyung University Dongsan Medical Center
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Daegu, Korea, Republic of, 42415
- Yeongnam University Medical Center (1526)
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Daegu, Korea, Republic of, 42415
- Yeongnam University Medical Center (1533)
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Daejeon, Korea, Republic of, 35015
- Chungnam National University Hospital
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Gwangju, Korea, Republic of, 61469
- Chonnam National University Hospital
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Gwangju, Korea, Republic of, 61453
- Chosun University Hospital
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Incheon, Korea, Republic of, 21565
- Gachon University Gil Medical Center
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Incheon, Korea, Republic of, 22332
- Inha University Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Korea, Republic of, 02447
- Kyung Hee University Hospital
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Seoul, Korea, Republic of, 02841
- Korea University Anam Hospital
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Seoul, Korea, Republic of, 01830
- Nowon Eulji Medical Center, Eulji University
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital (1512)
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital (1534)
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Seoul, Korea, Republic of, 04763
- Hanyang University Seoul Hospital
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Seoul, Korea, Republic of, 05368
- Veterans Health Service Medical Center
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Seoul, Korea, Republic of, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center (1519)
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center (1520)
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Seoul, Korea, Republic of, 07061
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
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Seoul, Korea, Republic of, 07441
- Hallym University, Kangnam Sacred Heart Hospital
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Seoul, Korea, Republic of, 08308
- Korea University Guro Hospital
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Chungcheongnam-do
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Cheonan, Chungcheongnam-do, Korea, Republic of, 31151
- Soon Chun Hyang University Hospital Cheonan
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Gangwon-do
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Gangneung, Gangwon-do, Korea, Republic of, 25440
- Gangneung Asan Hospital
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Wŏnju, Gangwon-do, Korea, Republic of, 26426
- Yonsei University, Wonju Severance Christian Hospital
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Gyeonggi-do
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Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
- Hallym University Medical Center
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Bucheon-si, Gyeonggi-do, Korea, Republic of, 14584
- Soon Chun Hyang University Hospital Bucheon
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Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
- Inje University Ilsan Paik Hospital
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Goyang-si, Gyeonggi-do, Korea, Republic of, 10444
- National Health Insurance Service Ilsan Hospital
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
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Suwon-si, Gyeonggi-do, Korea, Republic of, 16799
- Ajou University Hospital
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Gyeongsangnam-do
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Changwŏn, Gyeongsangnam-do, Korea, Republic of, 51353
- Samsung Changwon Hospital
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Jeollanam-do
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Suncheon, Jeollanam-do, Korea, Republic of, 57931
- St. Carollo General Hospital
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Jinju-si
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Gyeongsang, Jinju-si, Korea, Republic of, 52727
- Gyeongsang National University Hospital
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taichung, Taiwan, 40201
- Chung Shan Medical University Hospitial
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Beitou District
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Taipei, Beitou District, Taiwan, 11217
- Taipei Veterans General Hospital
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Guishan District
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Taoyuan, Guishan District, Taiwan, 33305
- Chang Gung Memorial Hospital, Linko
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Neihu District
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Taipei, Neihu District, Taiwan, 11490
- Tri-Service General Hospital
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Niaosong District
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Kaohsiung, Niaosong District, Taiwan, 83301
- Chang Gung Memorial Hospital, Kaohsiung
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Kaohsiung, Niaosong District, Taiwan, 83301
- Taichung Veterans General Hospitial
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Pai-Tou
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Taipei, Pai-Tou, Taiwan, 11220
- Cheng Hsin General Hospital
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Zhongzheng District
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Taipei, Zhongzheng District, Taiwan, 10002
- National Taiwan University Hospital
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Zuoying District
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Kaohsiung, Zuoying District, Taiwan, 81362
- Kaohsiung Veterans General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with NVAF and treated with edoxaban according to the package information.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Prescribed according to approved label
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of Participants Experiencing Real-World Safety Data Events within 2 Years
Time Frame: within 2 years
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Real-world safety data events include bleeding events (including intracranial haemorrhage), adverse events and mortality
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within 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of Participants with Patient Relevant Outcomes
Time Frame: within 2 years
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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.
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within 2 years
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Rate of Participants Compliant with Edoxaban Therapy
Time Frame: 2 years
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Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2017
Primary Completion (Actual)
October 15, 2020
Study Completion (Actual)
October 15, 2020
Study Registration Dates
First Submitted
October 28, 2016
First Submitted That Met QC Criteria
October 28, 2016
First Posted (Estimate)
November 1, 2016
Study Record Updates
Last Update Posted (Actual)
January 12, 2021
Last Update Submitted That Met QC Criteria
January 11, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DU176b-C-A4008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research.
This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.