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

NCT ID: NCT02951039

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3008 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2020-10-15

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Edoxaban

Intervention Type: DRUG

Prescribed according to approved label

Interventions

Edoxaban

Prescribed according to approved label

Intervention Type: DRUG

Other Intervention Names

Lixiana

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

Soon Chun Hyang University Hospital Cheonan

Cheonan, Chungcheongnam-do, South Korea

GangNeung Asan Hospital

Gangneung, Gangwon-do, South Korea

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Hallym University Medical Center

Anyang-si, Gyeonggi-do, South Korea

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, South Korea

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

National Health Insurance Service Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Samsung Changwon Hospital

Changwŏn, Gyeongsangnam-do, South Korea

St. Carollo General Hospital

Suncheon, Jeollanam-do, South Korea

Gyeongsang National University Hospital

Gyeongsang, Jinju-si, South Korea

Inje Universitiy Busan Paik Hospital

Busan, , South Korea

Inje University Haeundae Paik Hospital

Busan, , South Korea

Dong A University Hospital

Busan, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Yeongnam University Medical Center (1526)

Daegu, , South Korea

Yeongnam University Medical Center (1533)

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Chosun University Hospital

Gwangju, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Inha University Hospital

Incheon, , South Korea

Nowon Eulji Medical Center, Eulji University

Seoul, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seoul National University Hospital (1512)

Seoul, , South Korea

Seoul National University Hospital (1534)

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Hanyang University Seoul Hospital

Seoul, , South Korea

Veterans Health Service Medical Center

Seoul, , South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center (1519)

Seoul, , South Korea

Samsung Medical Center (1520)

Seoul, , South Korea

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Hallym University, Kangnam Sacred Heart Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

Chang Gung Memorial Hospital, Linko

Taoyuan District, Guishan District, Taiwan

Tri-Service General Hospital

Taipei, Neihu District, Taiwan

Chang Gung Memorial Hospital, KaoHsiung

Kaohsiung City, Niaosong District, Taiwan

Taichung Veterans General Hospitial

Kaohsiung City, Niaosong District, Taiwan

Cheng Hsin General Hospital

Taipei, Pai-Tou, Taiwan

National Taiwan University Hospital

Taipei, Zhongzheng District, Taiwan

KaoHsiung Veterans General Hospital

Kaohsiung City, Zuoying District, Taiwan

Chung Shan Medical University Hospitial

Taichung, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Countries

South Korea; Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 24251359 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40161305 (View on PubMed)

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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 38881370 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38098072 (View on PubMed)

Other Identifiers

DU176b-C-A4008

Identifier Type: -

Identifier Source: org_study_id