Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)

NCT02951039 | Completed

• 1 other identifier: DU176b-C-A4008
• Study Type: observational
• Target: 3,008
• Locations: 2 countries
• Sites: 47

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.

Conditions

Atrial Fibrillation

Keywords

Non valvular Atrial Fibrillation; Non-interventional Study; Efficacy/Safety; Real World Evidence

Outcome Measures

Primary Outcomes (1)

• 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

  within 2 years

Secondary Outcomes (2)

• Rate of Participants with Patient Relevant Outcomes

  within 2 years

• Rate of Participants Compliant with Edoxaban Therapy

  2 years

Study Arms (1)

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.

Drug: Edoxaban

Interventions

Edoxaban DRUG

Prescribed according to approved label

Also known as: Lixiana

Edoxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with NVAF and treated with edoxaban according to the package information.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (47)

Soon Chun Hyang University Hospital Cheonan

Cheonan, Chungcheongnam-do, 31151, South Korea

Location

GangNeung Asan Hospital

Gangneung, Gangwon-do, 25440, South Korea

Location

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Hallym University Medical Center

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, 14584, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

National Health Insurance Service Ilsan Hospital

Goyang-si, Gyeonggi-do, 10444, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16799, South Korea

Location

Samsung Changwon Hospital

Changwŏn, Gyeongsangnam-do, 51353, South Korea

Location

St. Carollo General Hospital

Suncheon, Jeollanam-do, 57931, South Korea

Location

Gyeongsang National University Hospital

Gyeongsang, Jinju-si, 52727, South Korea

Location

Inje Universitiy Busan Paik Hospital

Busan, 47392, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Dong A University Hospital

Busan, 49201, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Yeongnam University Medical Center (1526)

Daegu, 42415, South Korea

Location

Yeongnam University Medical Center (1533)

Daegu, 42415, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Chosun University Hospital

Gwangju, 61453, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 01830, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital (1512)

Seoul, 03080, South Korea

Location

Seoul National University Hospital (1534)

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

Veterans Health Service Medical Center

Seoul, 05368, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 06273, South Korea

Location

Samsung Medical Center (1519)

Seoul, 06351, South Korea

Location

Samsung Medical Center (1520)

Seoul, 06351, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Hallym University, Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

Location

Chang Gung Memorial Hospital, Linko

Taoyuan District, Guishan District, 33305, Taiwan

Location

Tri-Service General Hospital

Taipei, Neihu District, 11490, Taiwan

Location

Chang Gung Memorial Hospital, KaoHsiung

Kaohsiung City, Niaosong District, 83301, Taiwan

Location

Taichung Veterans General Hospitial

Kaohsiung City, Niaosong District, 83301, Taiwan

Location

Cheng Hsin General Hospital

Taipei, Pai-Tou, 11220, Taiwan

Location

National Taiwan University Hospital

Taipei, Zhongzheng District, 10002, Taiwan

Location

KaoHsiung Veterans General Hospital

Kaohsiung City, Zuoying District, 81362, Taiwan

Location

Chung Shan Medical University Hospitial

Taichung, 40201, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 24251359 BACKGROUND

• Morrone 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.

  PMID: 40161305 DERIVED

• De 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.

  PMID: 40014354 DERIVED

• Unverdorben 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.

  PMID: 38881370 DERIVED

• von 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.

  PMID: 38098072 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 1, 2016
• Study Start: February 21, 2017
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

KR (37); TW (10)