<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/NCT03292575</url>
  </required_header>
  <id_info>
    <org_study_id>Giroud 2016</org_study_id>
    <nct_id>NCT03292575</nct_id>
  </id_info>
  <brief_title>Study of the Follow-up of Stroke Treated With Anticoagulants</brief_title>
  <acronym>AOD</acronym>
  <official_title>Prevention of Cardio-embolic Stroke Using Anti-vitamin K and Direct Oral Anticoagulants. A Model of Action in Burgundy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke is a major public health problem as it is very frequent (140,000 cases/year in&#xD;
      France), and very serious (leading cause of death, 2nd leading cause of dementia, 3rd leading&#xD;
      cause of handicap). Ischemic cardio-embolic stroke accounts for around 25% of ischemic&#xD;
      strokes, and ischemic cardio-embolic stroke in a context of cardiac arrhythmia due to atrial&#xD;
      fibrillation (CAAF) is the leading non-atheromatous cause. The aim of this study is to&#xD;
      optimise the secondary prevention of CAAF-related stroke identified at the University&#xD;
      Hospital of Dijon Burgundy in the framework of the recommendations of the '2010-2014 stroke&#xD;
      plan' and the Compulsory Consultation at the 6th month (Directive DGOS//2015/262 of the 3rd&#xD;
      August 2015)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</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>rate of stroke recurrences</measure>
    <time_frame>12 months after inclusion</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">441</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Stroke related to CAAF</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anticoagulants</intervention_name>
    <arm_group_label>Stroke related to CAAF</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient with stroke resulting from occlusion of a cerebral artery (cerebral infarction)&#xD;
        with a clot detached from the heart that exhibits an arrhythmia by Auricular Fibrillation&#xD;
        or the occurrence of intracerebral hemorrhage&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients managed for stroke at the stroke unit of Dijon University Hospital for&#xD;
             CAAF-related cardio-embolic stroke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>June 3, 2019</last_update_submitted>
  <last_update_submitted_qc>June 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anticoagulants</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/NCT03292575
org study id: Giroud 2016
nct id: NCT03292575
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Stroke is a major public health problem as it is very frequent (140,000 cases/year in
      France), and very serious (leading cause of death, 2nd leading cause of dementia, 3rd leading
      cause of handicap). Ischemic cardio-embolic stroke accounts for around 25% of ischemic
      strokes, and ischemic cardio-embolic stroke in a context of cardiac arrhythmia due to atrial
      fibrillation (CAAF) is the leading non-atheromatous cause. The aim of this study is to
      optimise the secondary prevention of CAAF-related stroke identified at the University
      Hospital of Dijon Burgundy in the framework of the recommendations of the '2010-2014 stroke
      plan' and the Compulsory Consultation at the 6th month (Directive DGOS//2015/262 of the 3rd
      August 2015)
observational model: Cohort
time perspective: Prospective
measure: rate of stroke recurrences
time frame: 12 months after inclusion
arm group label: Stroke related to CAAF
intervention type: Drug
intervention name: Anticoagulants
arm group label: Stroke related to CAAF
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Stroke
mesh term: Anticoagulants