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Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951039
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date October 28, 2016
First Posted Date November 1, 2016
Last Update Posted Date January 12, 2021
Actual Study Start Date February 21, 2017
Actual Primary Completion Date October 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 28, 2016)
Rate of Participants Experiencing Real-World Safety Data Events within 2 Years [ Time Frame: within 2 years ]
Real-world safety data events include bleeding events (including intracranial haemorrhage), adverse events and mortality
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 28, 2016)
  • Rate of Participants with Patient Relevant Outcomes [ Time Frame: within 2 years ]
    Patient relevant outcomes include Strokes (ischaemic and haemorrhagic) , Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), and Hospitalisations related to a cardiovascular (CV) condition.
  • Rate of Participants Compliant with Edoxaban Therapy [ Time Frame: 2 years ]
    Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)
Official Title Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (NVAF)
Brief Summary In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this non-interventional study to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) and efficacy of edoxaban use in non-preselected patients with NVAF.
Detailed Description

Edoxaban was 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 NVAF, treatment of deep vein thrombosis (DVT) and pulmonary embolism. Edoxaban was approved by the 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 at least 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA), or treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), following 5 to 10 days of initial therapy with a parenteral anticoagulant.

Real world evidence data of routine clinical practice use of edoxaban up to two years will be collected and evaluated in approximately 2,500 patients, treated by specialized as well as non-specialized physicians in hospital centers.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with NVAF and treated with edoxaban according to the package information.
Condition Atrial Fibrillation
Intervention Drug: Edoxaban
Prescribed according to approved label
Other Name: Lixiana
Study Groups/Cohorts Edoxaban
Patients with established NVAF treated with edoxaban according to package information. 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.
Intervention: Drug: Edoxaban
Publications * Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 26, 2018)
3008
Original Estimated Enrollment
 (submitted: October 28, 2016)
2500
Actual Study Completion Date October 15, 2020
Actual Primary Completion Date October 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • NVAF-patients treated with edoxaban according to Summary of Product Characteristics (SmPC).
  • Written informed consent for participation in the study (ICF).
  • Not simultaneously participating in any interventional study.

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02951039
Other Study ID Numbers DU176b-C-A4008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
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/
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all 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, the European Union and/or Japan 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.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor Daiichi Sankyo, Inc.
Collaborators Not Provided
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date January 2021