<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/NCT02262676</url>
  </required_header>
  <id_info>
    <org_study_id>17671</org_study_id>
    <nct_id>NCT02262676</nct_id>
  </id_info>
  <brief_title>Observational Study to Assess Sociodemographic and Clinical Features of Patients Treated With Rivaroxaban in Routine Clinical Practice of Hematologists, Cardiologists and Internists of Spain</brief_title>
  <acronym>HEROIC</acronym>
  <official_title>Observational and Cross-sectional Study to Assess the Sociodemographic and Clinical Characteristics of Patients Treated With RIVAROXABAN in the Context of Routine Clinical Practice of Spanish Haematologists, Cardiologists and Internists (HEROIC Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depict demographic and clinical features of patients with atrial fibrillation treated with&#xD;
      rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Demographic Data</measure>
    <time_frame>At recruitment visit</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical History</measure>
    <time_frame>At recruitment visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess regional differences among the different Spanish autonomous communities on the management of patients with rivaroxaban treatment during the routine clinical practice</measure>
    <time_frame>At recruitment visit</time_frame>
    <description>By use of Informe de Posicionamiento Terapéutico (Spanish Questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to rivaroxaban treatment</measure>
    <time_frame>At recruitment visit</time_frame>
    <description>By use of Morisky-Green questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the satisfaction of rivaroxaban treatment</measure>
    <time_frame>At recruitment visit</time_frame>
    <description>By use of Anti-Clot Treatment Scale (ACTS) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the quality of life in patients</measure>
    <time_frame>At recruitment visit</time_frame>
    <description>By use of Short-Form 12 Health Survey,version 2 (SF12v2) questionnaire</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2251</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Rivaroxaban</arm_group_label>
    <description>Patients with Atrial fibrillation treated with Rivaroxaban</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban (Xarelto, BAY59-7939)</intervention_name>
    <description>Patients treated by Physicians under approved local prescriptions</description>
    <arm_group_label>Rivaroxaban</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients taking rivaroxaban for stroke prevention in atrial fibrillation attending consults&#xD;
        of hematology, cardiology and internal medicine&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥ 18 years&#xD;
&#xD;
          -  Patients with atrial fibrillation&#xD;
&#xD;
          -  Patients in treatment with rivaroxaban for stroke prevention in atrial fibrillation at&#xD;
             least 3 months previous to inclusion period in study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in treatment after start of study&#xD;
&#xD;
          -  Patients treated with other anticoagulant treatment&#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>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Many Locations</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke prevention on Atrial Fibrillation</keyword>
  <keyword>Prevention and Control</keyword>
  <keyword>Stroke</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>Rivaroxaban</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02262676
org study id: 17671
nct id: NCT02262676
lead sponsor: 
collaborator: 
has dmc: No
Depict demographic and clinical features of patients with atrial fibrillation treated with
      rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice
observational model: Cohort
time perspective: Cross-Sectional
measure: Demographic Data
time frame: At recruitment visit
measure: Medical History
time frame: At recruitment visit
measure: Assess regional differences among the different Spanish autonomous communities on the management of patients with rivaroxaban treatment during the routine clinical practice
time frame: At recruitment visit
description: By use of Informe de Posicionamiento Terapéutico (Spanish Questionnaire)
measure: Adherence to rivaroxaban treatment
time frame: At recruitment visit
description: By use of Morisky-Green questionnaire
measure: Assess the satisfaction of rivaroxaban treatment
time frame: At recruitment visit
description: By use of Anti-Clot Treatment Scale (ACTS) questionnaire
measure: Assess the quality of life in patients
time frame: At recruitment visit
description: By use of Short-Form 12 Health Survey,version 2 (SF12v2) questionnaire
arm group label: Rivaroxaban
description: Patients with Atrial fibrillation treated with Rivaroxaban
intervention type: Drug
intervention name: Rivaroxaban (Xarelto, BAY59-7939)
description: Patients treated by Physicians under approved local prescriptions
arm group label: Rivaroxaban
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Rivaroxaban