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

NCT02952599 | Completed

• 1 other identifier: DU176b-D-A4010
• Study Type: observational
• Target: 352
• Locations: 2 countries
• Sites: 19

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.

Conditions

Venous Thromboembolism

Keywords

Non-interventional Study; Real World Evidence; Patients with Acute VTE treated with Edoxaban; Efficacy/Safety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Rate of participants taking edoxaban with symptomatic VTE recurrence

  12 months

• Rate of participants who permanently discontinued edoxaban with symptomatic VTE recurrence

  12 months

• Rate of participants with patient relevant outcomes

  12 months

Study Arms (1)

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

Interventions

Edoxaban DRUG

Prescribed according to approved label

Also known as: Lixiana

Patients treated with Edoxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (19)

SoonChunHyang University Hospital Gumi

Gyeongsang, Gumi, 39371, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, Haeundae-gu, 48108, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Dong-A University Hospital

Seogu, Kwang-Jo Cho, South Korea

Location

Pusan National University Hospital

Busan, Seo-gu, 49241, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seodaemun-gu, 03722, South Korea

Location

SoonChunHyang University Hospital Seoul

Seoul, Yongsan-gu, 04401, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

Far Eastern Memorial Hospital

New Taipei City, Banciao District, 22060, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

Location

Chang Gung Memorial Hospital, KaoHsiung

Kaohsiung City, Niaosong District, 83301, Taiwan

Location

Cheng Hsin General Hospital

Taipei, Pai-Tou, 11220, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Shih Lin District, 11101, Taiwan

Location

National Taiwan University Hospital

Taipei, Zhongzheng District, 10002, Taiwan

Location

KaoHsiung Veterans General Hospital

Kaohsiung City, Zuoying District, 81362, Taiwan

Location

Changhua Christian Hospital

Chang-hua, 500, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 23991658 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: March 27, 2017
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

TW (10); KR (9)