Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Korea and Taiwan (ETNA-VTE-KOR-TWN)
NCT ID: NCT02952599
Last Updated: 2019-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
352 participants
OBSERVATIONAL
2017-03-27
2019-10-29
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients treated with Edoxaban
Patients with established acute initial or recurrent VTE treated with edoxaban according to Summary of Product Characteristics (SmPC). 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
Prescribed according to approved label
Interventions
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Edoxaban
Prescribed according to approved label
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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SoonChunHyang University Hospital Gumi
Gyeongsang, Gumi, South Korea
Inje University Haeundae Paik Hospital
Busan, Haeundae-gu, South Korea
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Dong-A University Hospital
Seogu, Kwang-Jo Cho, South Korea
Pusan National University Hospital
Busan, Seo-gu, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu, South Korea
SoonChunHyang University Hospital Seoul
Seoul, Yongsan-gu, South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, , South Korea
Far Eastern Memorial Hospital
New Taipei City, Banciao District, Taiwan
Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan
Chang Gung Memorial Hospital, KaoHsiung
Kaohsiung City, Niaosong District, Taiwan
Cheng Hsin General Hospital
Taipei, Pai-Tou, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Shih Lin District, Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng District, Taiwan
KaoHsiung Veterans General Hospital
Kaohsiung City, Zuoying District, Taiwan
Changhua Christian Hospital
Chang-hua, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Countries
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References
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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.
Other Identifiers
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DU176b-D-A4010
Identifier Type: -
Identifier Source: org_study_id