<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/NCT03012906</url>
  </required_header>
  <id_info>
    <org_study_id>2016-16</org_study_id>
    <nct_id>NCT03012906</nct_id>
  </id_info>
  <brief_title>Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score &gt;1 Undergoing Percutaneous Coronary Interventions</brief_title>
  <official_title>Prospective Multicenter Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score &gt;1 Undergoing Percutaneous Coronary Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and&#xD;
      requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc &gt;1 are&#xD;
      required to receive triple antithrombotic therapy . This triple therapy includes dual&#xD;
      antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant&#xD;
      with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).&#xD;
&#xD;
      Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the&#xD;
      coagulation cascade have demonstrated non inferiority compared to VKA to prevent&#xD;
      thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc &gt;1 .&#xD;
      Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA.&#xD;
      Overall they seem to result in a lower bleeding rate compared to VKA in association with&#xD;
      antiplatelet agents.&#xD;
&#xD;
      Recently European guidelines regarding patients requiring chronic anticoagulant therapy and&#xD;
      undergoing coronary stent implantation have been updated. However they are based on an expert&#xD;
      consensus because of the scarce data available.&#xD;
&#xD;
      These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and&#xD;
      aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5&#xD;
      . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and&#xD;
      thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines&#xD;
      suggest that a sole antiplatelet agent could be used in addition to anticoagulation following&#xD;
      the WOEST study . In the recently published ESC guidelines on the management of atrial&#xD;
      fibrillation, despite the lack of new data, the expert advocate triple therapy followed by&#xD;
      dual antiplatelet therapy in most patients for 12 months.&#xD;
&#xD;
      The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in&#xD;
      these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban&#xD;
      15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically&#xD;
      relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar&#xD;
      efficacy .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Number of deaths</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of myocardial infarctions</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of strokes</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The prevalence of bleeding events</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Percutaneous Coronary Intervention</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>the prevalence of ischemic events</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing percutaneous coronary intervention (PCI)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age over 18 years old&#xD;
&#xD;
          2. signed informed consent&#xD;
&#xD;
          3. requiring PCI (with stent placement) with subsequent need for antiplatelet therapy&#xD;
&#xD;
          4. FA requiring chronic anticoagulation (CHA2DS2-VASc &gt;1, except women with a score =1).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. pregnancy or lactation&#xD;
&#xD;
          2. age &lt;18 or not able to give an informed consent&#xD;
&#xD;
          3. no informed consent&#xD;
&#xD;
          4. no health insurance&#xD;
&#xD;
          5. prisoners&#xD;
&#xD;
          6. contra indication to antiplatelet therapy&#xD;
&#xD;
          7. intra cardiac thrombus&#xD;
&#xD;
          8. active bleeding Known bleeding diathesis (i.e. history of ICH, GI bleeding)&#xD;
&#xD;
          9. severe kidney failure (eGFR &lt; 30 mL/min/1.73 m²)&#xD;
&#xD;
         10. severe hepatic failure (Child-Pugh class B or C)&#xD;
&#xD;
         11. contra indication to OAC or VKA&#xD;
&#xD;
         12. hypertrophic myocardiopathy&#xD;
&#xD;
         13. valvular prosthesis&#xD;
&#xD;
         14. history of peptic ulcer&#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>Catherine GEINDRE</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laurent bonello</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurent bonello</last_name>
    <email>laurent.bonello@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</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>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03012906
org study id: 2016-16
nct id: NCT03012906
lead sponsor: 
has dmc: No
Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and
      requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are
      required to receive triple antithrombotic therapy . This triple therapy includes dual
      antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant
      with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).

      Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the
      coagulation cascade have demonstrated non inferiority compared to VKA to prevent
      thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 .
      Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA.
      Overall they seem to result in a lower bleeding rate compared to VKA in association with
      antiplatelet agents.

      Recently European guidelines regarding patients requiring chronic anticoagulant therapy and
      undergoing coronary stent implantation have been updated. However they are based on an expert
      consensus because of the scarce data available.

      These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and
      aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5
      . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and
      thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines
      suggest that a sole antiplatelet agent could be used in addition to anticoagulation following
      the WOEST study . In the recently published ESC guidelines on the management of atrial
      fibrillation, despite the lack of new data, the expert advocate triple therapy followed by
      dual antiplatelet therapy in most patients for 12 months.

      The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in
      these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban
      15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically
      relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar
      efficacy .
observational model: Cohort
time perspective: Prospective
measure: Number of deaths
time frame: 2 years
measure: Number of myocardial infarctions
time frame: 2 years
measure: Number of strokes
time frame: 2 years
measure: The prevalence of bleeding events
time frame: 2 years
intervention type: Other
intervention name: the prevalence of ischemic events
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Catherine GEINDRE
role: Study Director
affiliation: Assistance Publique Hopitaux De Marseille
last name: Laurent bonello
role: Principal Investigator
affiliation: Assistance Publique Hopitaux De Marseille
last name: Laurent bonello
email: laurent.bonello@ap-hm.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No