Clinical trial NCT02951039: Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)
Official title: Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (NVAF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Non valvular Atrial Fibrillation
Non-interventional Study
Efficacy/Safety
Real World Evidence
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 3008
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with NVAF and treated with edoxaban according to the package information.

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.

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

Primary outcomes:
measure: Rate of Participants Experiencing Real-World Safety Data Events within 2 Years
timeFrame: within 2 years
Secondary outcomes:
measure: Rate of Participants with Patient Relevant Outcomes
timeFrame: within 2 years
measure: Rate of Participants Compliant with Edoxaban Therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
state: Chungcheongnam-do
city: Gangneung
country: Korea, Republic of
facility: GangNeung Asan Hospital
state: Gangwon-do
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University, Wonju Severance Christian Hospital
state: Gangwon-do
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Medical Center
state: Gyeonggi-do
city: Bucheon-si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Changwŏn
country: Korea, Republic of
facility: Samsung Changwon Hospital
state: Gyeongsangnam-do
city: Suncheon
country: Korea, Republic of
facility: St. Carollo General Hospital
state: Jeollanam-do
city: Gyeongsang
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Jinju-si
city: Busan
country: Korea, Republic of
facility: Inje Universitiy Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong A University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeongnam University Medical Center (1526)
city: Daegu
country: Korea, Republic of
facility: Yeongnam University Medical Center (1533)
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital (1512)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital (1534)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Veterans Health Service Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center (1519)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center (1520)
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University, Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: Beitou District
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linko
state: Guishan District
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
state: Neihu District
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital, KaoHsiung
state: Niaosong District
city: Kaohsiung
country: Taiwan
facility: Taichung Veterans General Hospitial
state: Niaosong District
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
state: Pai-Tou
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng District
city: Kaohsiung
country: Taiwan
facility: KaoHsiung Veterans General Hospital
state: Zuoying District
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospitial
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: 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.