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

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Drug: Edoxaban

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.

• Study Type: Observational
• Enrollment (Actual): 352

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Wŏnju, Korea, Republic of, 26426
    • Yonsei University, Wonju Severance Christian Hospital
  • Gumi
    • Gyeongsang, Gumi, Korea, Republic of, 39371
      • SoonChunHyang University Hospital Gumi
  • Haeundae-gu
    • Busan, Haeundae-gu, Korea, Republic of, 48108
      • Inje University Haeundae Paik Hospital
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital
  • Kwang-Jo Cho
    • Seogu, Kwang-Jo Cho, Korea, Republic of
      • Dong-a University hospital
  • Seo-gu
    • Busan, Seo-gu, Korea, Republic of, 49241
      • Pusan National University Hospital
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, Korea, Republic of, 03722
      • Severance Hospital, Yonsei University Health System
  • Yongsan-gu
    • Seoul, Yongsan-gu, Korea, Republic of, 04401
      • Soonchunhyang University Hospital Seoul
• Taiwan
  • Chang-hua, Taiwan, 500
    • Changhua Christian Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Banciao District
    • New Taipei City, Banciao District, Taiwan, 22060
      • Far Eastern Memorial Hospital
  • Beitou District
    • Taipei, Beitou District, Taiwan, 11217
      • Taipei Veterans General Hospital
  • Niaosong District
    • Kaohsiung, Niaosong District, Taiwan, 83301
      • Chang Gung Memorial Hospital, Kaohsiung
  • Pai-Tou
    • Taipei, Pai-Tou, Taiwan, 11220
      • Cheng Hsin General Hospital
  • Shih Lin District
    • Taipei, Shih Lin District, Taiwan, 11101
      • Shin Kong Wu Ho-Su Memorial Hospital
  • Zhongzheng District
    • Taipei, Zhongzheng District, Taiwan, 10002
      • National Taiwan University Hospital
  • Zuoying District
    • Kaohsiung, Zuoying District, Taiwan, 81362
      • Kaohsiung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Edoxaban; Prescribed according to approved label; Other Names: Lixiana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of overall symptomatic VTE recurrence	Rate of overall symptomatic VTE recurrence within 12 months	Baseline to 12 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of participants taking edoxaban with symptomatic VTE recurrence	Rate of participants taking edoxaban with symptomatic VTE recurrence in 12 months	12 months
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
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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Publications and helpful links

General Publications

• 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. Erratum In: N Engl J Med. 2014 Jan 23;370(4):390.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2017
• Primary Completion (ACTUAL): October 29, 2019
• Study Completion (ACTUAL): October 29, 2019

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (ESTIMATE): November 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Non-interventional Study; Efficacy/Safety; Real World Evidence; Patients with Acute VTE treated with Edoxaban
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban
• Other Study ID Numbers: DU176b-D-A4010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received EU and US marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States and the European Union from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR