Atrial FibrillationNCT02951039
Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)
An observational study of Atrial Fibrillation, run by Daiichi Sankyo at 47 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Edoxaban
- How many people
- 3,008 participants
- Where
- 47 sitesin 2 countries
- Study dates
- 21 Feb 2017to 15 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with NVAF and treated with edoxaban according to the package information.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
47 sites in 2 countries.
47 sites in 2 countries
South Korea37 sites
Hallym University Medical Center
Anyang-si, Gyeonggi-do, 14068
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, 14584
Inje Universitiy Busan Paik Hospital
Busan, 47392
Inje University Haeundae Paik Hospital
Busan, 48108
Dong A University Hospital
Busan, 49201
Samsung Changwon Hospital
Changwŏn, Gyeongsangnam-do, 51353
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, 31151
Keimyung University Dongsan Medical Center
Daegu, 41931
Yeongnam University Medical Center (1526)
Daegu, 42415
Yeongnam University Medical Center (1533)
Daegu, 42415
Chungnam National University Hospital
Daejeon, 35015
GangNeung Asan Hospital
Gangneung, Gangwon-do, 25440
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 10380
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, 10444
Chosun University Hospital
Gwangju, 61453
Chonnam National University Hospital
Gwangju, 61469
Gyeongsang National University Hospital
Gyeongsang, Jinju-si, 52727
Gachon University Gil Medical Center
Incheon, 21565
Inha University Hospital
Incheon, 22332
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
Kyung Hee University Hospital
Seoul, 02447
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital (1512)
Seoul, 03080
Seoul National University Hospital (1534)
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Hanyang University Seoul Hospital
Seoul, 04763
Veterans Health Service Medical Center
Seoul, 05368
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Samsung Medical Center (1519)
Seoul, 06351
Samsung Medical Center (1520)
Seoul, 06351
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061
Hallym University, Kangnam Sacred Heart Hospital
Seoul, 07441
Korea University Guro Hospital
Seoul, 08308
St. Carollo General Hospital
Suncheon, Jeollanam-do, 57931
Ajou University Hospital
Suwon, Gyeonggi-do, 16799
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Taiwan10 sites
Chang Gung Memorial Hospital, KaoHsiung
Kaohsiung City, Niaosong District, 83301
Taichung Veterans General Hospitial
Kaohsiung City, Niaosong District, 83301
KaoHsiung Veterans General Hospital
Kaohsiung City, Zuoying District, 81362
Chung Shan Medical University Hospitial
Taichung, 40201
China Medical University Hospital
Taichung, 40447
Taipei Veterans General Hospital
Taipei, Beitou District, 11217
Tri-Service General Hospital
Taipei, Neihu District, 11490
Cheng Hsin General Hospital
Taipei, Pai-Tou, 11220
National Taiwan University Hospital
Taipei, Zhongzheng District, 10002
Chang Gung Memorial Hospital, Linko
Taoyuan, Guishan District, 33305
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Edoxaban
- Keywords
- Non valvular Atrial Fibrillation, Non-interventional Study, Efficacy/Safety, Real World Evidence
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Also called Lixiana
Prescribed according to approved label
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Participants Experiencing Real-World Safety Data Events within 2 Years
Real-world safety data events include bleeding events (including intracranial haemorrhage), adverse events and mortality
Measured: within 2 years
Secondary outcomes (2)
Rate of Participants with Patient Relevant Outcomes
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.
Measured: within 2 years
Rate of Participants Compliant with Edoxaban Therapy
Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start21 Feb 2017
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951039
- Sponsor's protocol ID
- DU176b-C-A4008
- Status last verified
- Jan 2021
- First submitted
- 28 Oct 2016
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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/
Publications
Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.
PubMed 24251359Morrone D, Dinshaw L, de Souza JAG, Chen C, Kirchhof P, Koretsune Y, Pecen L, Wang CC, Yamashita T, Unverdorben M, De Caterina R. Edoxaban treatment in routine clinical practice is highly concordant with the 2020 European Society of Cardiology atrial fibrillation guidelines: results from the noninterventional Global ETNA-AF programme. Eur Heart J Open. 2025 Mar 28;5(2):oeaf004. doi: 10.1093/ehjopen/oeaf004. eCollection 2025 Mar.
PubMed 40161305De Caterina R, Unverdorben M, Chen C, Choi EK, Koretsune Y, Morrone D, Pecen L, Bramlage P, Wang CC, Yamashita T, Kirchhof P. Two-Year Follow-Up of Patients With Atrial Fibrillation Receiving Edoxaban in Routine Clinical Practice: Results From the Global ETNA-AF Program. Clin Cardiol. 2025 Feb;48(3):e70091. doi: 10.1002/clc.70091.
PubMed 40014354Unverdorben M, Colonna P, Jin J, Kohler S, Santamaria A, Saxena M, Borrow A, Chen C, von Heymann C, Vanassche T. Periprocedural Edoxaban Management and Clinical Outcomes in Patients Undergoing Transcatheter Cardiovascular Procedures in the EMIT-AF/VTE Program. Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241260728. doi: 10.1177/10760296241260728.
PubMed 38881370von Heymann C, Unverdorben M, Colonna P, Santamaria A, Saxena M, Vanassche T, Kohler S, Borrow AP, Jin J, Chen C. Management of edoxaban therapy and clinical outcomes in patients undergoing major or nonmajor surgery: a subanalysis of the EMIT-AF/VTE study. Thromb J. 2023 Dec 14;21(1):124. doi: 10.1186/s12959-023-00568-2.
PubMed 38098072
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (NVAF)
- ClinicalTrials.gov ID
- NCT02951039
- Acronym / sponsor ID
- DU176b-C-A4008
- Conditions
- Atrial Fibrillation
- Keywords
- Non valvular Atrial Fibrillation, Non-interventional Study, Efficacy/Safety, Real World Evidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,008 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edoxaban | – | Drug: EdoxabanPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with NVAF and treated with edoxaban according to the package information.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanAlso: LixianaPrescribed according to approved label | Drug | Edoxaban |
Primary outcome
Rate of Participants Experiencing Real-World Safety Data Events within 2 Years
Time frame: within 2 years
Real-world safety data events include bleeding events (including intracranial haemorrhage), adverse events and mortality
2 secondary outcomes
Rate of Participants with Patient Relevant Outcomes
Time frame: within 2 years
Rate of Participants Compliant with Edoxaban Therapy
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Background: PubMed 24251359Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.
- Derived from this study: PubMed 40161305Morrone D, Dinshaw L, de Souza JAG, Chen C, Kirchhof P, Koretsune Y, Pecen L, Wang CC, Yamashita T, Unverdorben M, De Caterina R. Edoxaban treatment in routine clinical practice is highly concordant with the 2020 European Society of Cardiology atrial fibrillation guidelines: results from the noninterventional Global ETNA-AF programme. Eur Heart J Open. 2025 Mar 28;5(2):oeaf004. doi: 10.1093/ehjopen/oeaf004. eCollection 2025 Mar.
- Derived from this study: PubMed 40014354De Caterina R, Unverdorben M, Chen C, Choi EK, Koretsune Y, Morrone D, Pecen L, Bramlage P, Wang CC, Yamashita T, Kirchhof P. Two-Year Follow-Up of Patients With Atrial Fibrillation Receiving Edoxaban in Routine Clinical Practice: Results From the Global ETNA-AF Program. Clin Cardiol. 2025 Feb;48(3):e70091. doi: 10.1002/clc.70091.
- Derived from this study: PubMed 38881370Unverdorben M, Colonna P, Jin J, Kohler S, Santamaria A, Saxena M, Borrow A, Chen C, von Heymann C, Vanassche T. Periprocedural Edoxaban Management and Clinical Outcomes in Patients Undergoing Transcatheter Cardiovascular Procedures in the EMIT-AF/VTE Program. Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241260728. doi: 10.1177/10760296241260728.
- Derived from this study: PubMed 38098072von Heymann C, Unverdorben M, Colonna P, Santamaria A, Saxena M, Vanassche T, Kohler S, Borrow AP, Jin J, Chen C. Management of edoxaban therapy and clinical outcomes in patients undergoing major or nonmajor surgery: a subanalysis of the EMIT-AF/VTE study. Thromb J. 2023 Dec 14;21(1):124. doi: 10.1186/s12959-023-00568-2.
- Individual participant dataSharing planned: Yes. 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/
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
47 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Daiichi Sankyo at 47 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Participants Experiencing Real-World Safety Data Events within 2 Years (time frame: within 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02951039, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.