<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03247582</url>
  </required_header>
  <id_info>
    <org_study_id>DU176b-C-A4012</org_study_id>
    <nct_id>NCT03247582</nct_id>
  </id_info>
  <brief_title>Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)</brief_title>
  <official_title>Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo Hong Kong Ltd., a Daiichi Sankyo Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daiichi Sankyo, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In order to understand the risks and benefits of edoxaban use in a real-world clinical&#xD;
      setting in the NVAF indication, Daiichi-Sankyo Hong Kong proposed this non-interventional&#xD;
      study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with&#xD;
      NVAF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Edoxaban was approved by the Pharmacy and Poisons Board in Hong Kong (date: 31 May 2016) for&#xD;
      the: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial&#xD;
      fibrillation (NVAF) with one or more risk factors, such as congestive heart failure,&#xD;
      hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack&#xD;
      (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of&#xD;
      recurrent DVT and PE in adults.&#xD;
&#xD;
      In order to understand the risks and benefits of edoxaban use in a real-world clinical&#xD;
      setting in the NVAF indication, Daiichi-Sankyo proposed this non-interventional study (NIS)&#xD;
      to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.&#xD;
&#xD;
      Real world evidence from routine clinical practice using edoxaban up to 2 years will be&#xD;
      collected and evaluated in approximately 200 patients, treated by specialized as well as&#xD;
      non-specialized physicians in hospital centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Actual">May 3, 2022</completion_date>
  <primary_completion_date type="Actual">May 3, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with real world safety events</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with patient relevant outcomes</measure>
    <time_frame>2 years</time_frame>
    <description>Categories: Strokes (ischaemic and haemorrhagic), Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), Hospitalisations related to cardiovascular (CV) condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average duration of exposure to edoxaban</measure>
    <time_frame>within 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants compliant with edoxaban therapy</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">234</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Edoxaban</arm_group_label>
    <description>NVAF Patients treated with Edoxaban</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Edoxaban</intervention_name>
    <description>Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).</description>
    <arm_group_label>Edoxaban</arm_group_label>
    <other_name>Lixiana</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary strategy is to include only patients with NVAF who are to be treated with edoxaban&#xD;
        according to Package Information (Summary of Product Characteristics (SmPC)). To ensure&#xD;
        that the physician's prescribing behaviour will not be influenced, patients may only be&#xD;
        included after the treating physician has made the clinical decision to prescribe edoxaban.&#xD;
        Patients must have provided written informed consent for participation in the study (ICF)&#xD;
        and should not participate simultaneously in any interventional study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is a NVAF-patient whose physician has made the clinical decision to prescribe edoxaban&#xD;
             therapy according to Package Information&#xD;
&#xD;
          -  Has provided written informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is participating in an interventional study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Late Phase Operations Lead, Global Medical Affairs</last_name>
    <role>Study Director</role>
    <affiliation>Daiichi Sankyo, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Study Project Manager</last_name>
    <role>Study Chair</role>
    <affiliation>Daiichi Sankyo (Hong Kong), Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prince of Wales Hospital (1082)</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital (1083)</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital, Department of Cardiology (1801)</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital, Department of Neurology (1805)</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar 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.</citation>
    <PMID>24251359</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Real World Evidence</keyword>
  <keyword>Non-valvular Atrial Fibrillation</keyword>
  <keyword>Observational Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Edoxaban</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_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.</ipd_time_frame>
    <ipd_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.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/daiichi-sankyo/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03247582
org study id: DU176b-C-A4012
nct id: NCT03247582
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
In order to understand the risks and benefits of edoxaban use in a real-world clinical
      setting in the NVAF indication, Daiichi-Sankyo Hong Kong proposed this non-interventional
      study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with
      NVAF.
Edoxaban was approved by the Pharmacy and Poisons Board in Hong Kong (date: 31 May 2016) for
      the: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial
      fibrillation (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), and prevention of
      recurrent DVT and PE in adults.

      In order to understand the risks and benefits of edoxaban use in a real-world clinical
      setting in the NVAF indication, Daiichi-Sankyo proposed this non-interventional study (NIS)
      to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.

      Real world evidence from routine clinical practice using edoxaban up to 2 years will be
      collected and evaluated in approximately 200 patients, treated by specialized as well as
      non-specialized physicians in hospital centers.
observational model: Cohort
time perspective: Prospective
measure: Number of participants with real world safety events
time frame: 2 years
measure: Number of participants with patient relevant outcomes
time frame: 2 years
description: Categories: Strokes (ischaemic and haemorrhagic), Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), Hospitalisations related to cardiovascular (CV) condition
measure: Average duration of exposure to edoxaban
time frame: within 2 years
measure: Number of participants compliant with edoxaban therapy
time frame: 2 years
arm group label: Edoxaban
description: NVAF Patients treated with Edoxaban
intervention type: Drug
intervention name: Edoxaban
description: Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
arm group label: Edoxaban
other name: Lixiana
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Late Phase Operations Lead, Global Medical Affairs
role: Study Director
affiliation: Daiichi Sankyo, Inc.
last name: Study Project Manager
role: Study Chair
affiliation: Daiichi Sankyo (Hong Kong), Ltd.
facility: 
facility: 
facility: 
facility: 
country: Hong Kong
citation: Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar 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.
PMID: 24251359
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Edoxaban
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd 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.
ipd 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.
ipd url: https://vivli.org/ourmember/daiichi-sankyo/