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

Atrial Fibrillation Clinical Trial

Official title:

Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (NVAF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951039
• Other study ID #: DU176b-C-A4008
• Status: Completed
• Start date: February 21, 2017
• Est. completion date: October 15, 2020

Study information

• Verified date: January 2021
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 adverse events) and efficacy of edoxaban use in non-preselected patients with NVAF.

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 information / eligibility

• Status: Completed
• Enrollment: 3008
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Edoxaban
Prescribed according to approved label

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Countries where clinical trial is conducted

Korea, Republic of,  Taiwan, 

References & Publications (1)

Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	within 2 years
Secondary	Rate of Participants Compliant with Edoxaban Therapy	Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown	2 years