Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Korea and Taiwan (ETNA-VTE-KOR-TWN)

Venous Thromboembolism Clinical Trial

Official title:

Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism (VTE) in Korea and Taiwan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952599
• Other study ID #: DU176b-D-A4010
• Status: Completed
• Start date: March 27, 2017
• Est. completion date: October 29, 2019

Study information

• Verified date: December 2019
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Edoxaban
Prescribed according to approved label

Locations

Country	Name	City	State
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan	Haeundae-gu
Korea, Republic of	Pusan National University Hospital	Busan	Seo-gu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	SoonChunHyang University Hospital Gumi	Gyeongsang	Gumi
Korea, Republic of	Dong-A University Hospital	Seogu	Kwang-Jo Cho
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seodaemun-gu
Korea, Republic of	SoonChunHyang University Hospital Seoul	Seoul	Yongsan-gu
Korea, Republic of	Yonsei University, Wonju Severance Christian Hospital	Wonju
Taiwan	Changhua Christian Hospital	Chang-hua
Taiwan	Chang Gung Memorial Hospital, KaoHsiung	Kaohsiung	Niaosong District
Taiwan	KaoHsiung Veterans General Hospital	Kaohsiung	Zuoying District
Taiwan	Far Eastern Memorial Hospital	New Taipei City	Banciao District
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Cheng Hsin General Hospital	Taipei	Pai-Tou
Taiwan	National Taiwan University Hospital	Taipei	Zhongzheng District
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei	Shih Lin District
Taiwan	Taipei Veterans General Hospital	Taipei	Beitou District

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Countries where clinical trial is conducted

Korea, Republic of,  Taiwan, 

References & Publications (1)

Hokusai-VTE Investigators, Büller HR, Décousus 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. Erratum in: N Engl J Med. 2014 Jan 23;370(4):390. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of overall symptomatic VTE recurrence	Rate of overall symptomatic VTE recurrence within 12 months	Baseline to 12 months
Primary	Rate of participants experiencing Real World Safety Data Events	Categories: VTE-related bleeding events, Drug-related adverse events, Cardiovascular Mortality, and All-cause Mortality	12 months
Secondary	Rate of participants taking edoxaban with symptomatic VTE recurrence	Rate of participants taking edoxaban with symptomatic VTE recurrence in 12 months	12 months
Secondary	Rate of participants who permanently discontinued edoxaban with symptomatic VTE recurrence	Rate of participants who permanently discontinued edoxaban with symptomatic VTE recurrence in 12 months	12 months
Secondary	Rate of participants with patient relevant outcomes	Patient relevant outcomes include bleeding events, strokes (ischaemic and haemorrhagic), systemic embolic events (SEE), and hospitalisations related to cardiovascular (CV) condition (including VTE related hospitalisation).	12 months