Clinical trial NCT02952599: Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Korea and Taiwan (ETNA-VTE-KOR-TWN)
Official title: Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism (VTE) in Korea and Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Non-interventional Study
Real World Evidence
Patients with Acute VTE treated with Edoxaban
Efficacy/Safety
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 352
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 established acute initial or recurrent VTE treated with edoxaban according to package information. To ensure that the 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. Patients must have provided written informed consent for participation in the study (ICF) and should not participate simultaneously in any interventional study.

Brief summary: According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months.

Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in an unselected patient population in routine clinical practice.

Detailed description: Edoxaban is an orally administered anticoagulant that inhibits coagulation factor Xa. It has been 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 non valvular atrial fibrillation (NVAF) Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) Reduction in the risk of recurrent DVT and PE, and by 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 ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.

According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months.

This non-interventional study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in approximately 350 patients in an unselected patient population in routine clinical practice.

Eligibility criteria: Inclusion Criteria:

* Established acute initial or recurrent VTE
* Patients prescribed treatment with edoxaban according to package information before participation in the trial
* Written informed consent for participation in the study (ICF)
* Not simultaneously participating in any interventional study

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of overall symptomatic VTE recurrence
timeFrame: Baseline to 12 months
measure: Rate of participants experiencing Real World Safety Data Events
timeFrame: 12 months
Secondary outcomes:
measure: Rate of participants taking edoxaban with symptomatic VTE recurrence
timeFrame: 12 months
measure: Rate of participants who permanently discontinued edoxaban with symptomatic VTE recurrence
timeFrame: 12 months
measure: Rate of participants with patient relevant outcomes
timeFrame: 12 months
Other outcomes:
Locations:
city: Gyeongsang
country: Korea, Republic of
facility: SoonChunHyang University Hospital Gumi
state: Gumi
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Haeundae-gu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
city: Seogu
country: Korea, Republic of
facility: Dong-A University Hospital
state: Kwang-Jo Cho
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Seo-gu
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seodaemun-gu
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Hospital Seoul
state: Yongsan-gu
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University, Wonju Severance Christian Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Banciao District
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: Beitou District
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital, KaoHsiung
state: Niaosong District
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
state: Pai-Tou
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
state: Shih Lin District
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: Chang-hua
country: Taiwan
facility: Changhua Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31.