<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/NCT02974777</url>
  </required_header>
  <id_info>
    <org_study_id>IDEAL-PCI v.2</org_study_id>
    <nct_id>NCT02974777</nct_id>
  </id_info>
  <brief_title>The IDEAL-PCI Extended Registry</brief_title>
  <acronym>IDEAL-PCI ext</acronym>
  <official_title>Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Extended Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Franz Josef Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Franz Josef Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the efficacy and safety of a routine individualized&#xD;
      antiplatelet therapy after coronary stent implantation by evaluating &quot;on-treatment&quot; platelet&#xD;
      reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).&#xD;
&#xD;
      IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on&#xD;
      bleeding events and net clinical benefit&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Determination of platelet reactivity in patients with percutaneous coronary Intervention as&#xD;
      described in the IDEAL-PCI registry.&#xD;
&#xD;
      In the IDEAL-PCI Extended Registry an additional deescalation arm with reduction of the&#xD;
      standard dual antiplatelet therapy (DAPT) dosis in case of low platelet reactivity to P2Y12&#xD;
      Inhibition or Aspirin with or without bleeding is implemented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    not started due to regulatory reasons&#xD;
  </why_stopped>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>stent thrombosis</measure>
    <time_frame>1 year</time_frame>
    <description>stent thrombosis by any Academic Research Consortium (ARC) definition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>bleeding</measure>
    <time_frame>1 year</time_frame>
    <description>bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac and cerebrovascular Events (MACCE)</measure>
    <time_frame>1 year</time_frame>
    <description>death, cardiovascular death, myocardial infarction, stroke, ischemia driven revascularization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Coronary Arterioscleroses</condition>
  <condition>Platelet Dysfunction Due to Drugs</condition>
  <arm_group>
    <arm_group_label>Bleeding prevention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ischemia prevention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAPT reduction</intervention_name>
    <description>Reduction of standard dose DAPT due to low platelet reactivity</description>
    <arm_group_label>Bleeding prevention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAPT on-target</intervention_name>
    <description>Standard DAPT within the therapeutic window of platelet reactivity</description>
    <arm_group_label>Bleeding prevention group</arm_group_label>
    <arm_group_label>Ischemia prevention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAPT intensification</intervention_name>
    <description>Intensification of standard dose DAPT due to high platelet reactivity</description>
    <arm_group_label>Ischemia prevention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all consecutive PCI patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guenter Christ, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Franz Josef Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Franz Josef Hospital</name>
      <address>
        <city>Vienna</city>
        <zip>1100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.gov/ct2/show/NCT01515345</url>
    <description>IDEAL-PCI Registry</description>
  </link>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>January 25, 2018</last_update_submitted>
  <last_update_submitted_qc>January 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaiser Franz Josef Hospital</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Guenter Christ</investigator_full_name>
    <investigator_title>Prof</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteriosclerosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_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/NCT02974777
org study id: IDEAL-PCI v.2
nct id: NCT02974777
lead sponsor: 
The purpose of this study is to determine the efficacy and safety of a routine individualized
      antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet
      reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).

      IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on
      bleeding events and net clinical benefit
Determination of platelet reactivity in patients with percutaneous coronary Intervention as
      described in the IDEAL-PCI registry.

      In the IDEAL-PCI Extended Registry an additional deescalation arm with reduction of the
      standard dual antiplatelet therapy (DAPT) dosis in case of low platelet reactivity to P2Y12
      Inhibition or Aspirin with or without bleeding is implemented.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: stent thrombosis
time frame: 1 year
description: stent thrombosis by any Academic Research Consortium (ARC) definition
measure: bleeding
time frame: 1 year
description: bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition
measure: Major adverse cardiac and cerebrovascular Events (MACCE)
time frame: 1 year
description: death, cardiovascular death, myocardial infarction, stroke, ischemia driven revascularization
arm group label: Bleeding prevention group
arm group type: Active Comparator
description: Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor
arm group label: Ischemia prevention group
arm group type: Active Comparator
description: Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor
intervention type: Drug
intervention name: DAPT reduction
description: Reduction of standard dose DAPT due to low platelet reactivity
arm group label: Bleeding prevention group
intervention type: Drug
intervention name: DAPT on-target
description: Standard DAPT within the therapeutic window of platelet reactivity
arm group label: Bleeding prevention group
arm group label: Ischemia prevention group
intervention type: Drug
intervention name: DAPT intensification
description: Intensification of standard dose DAPT due to high platelet reactivity
arm group label: Ischemia prevention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Guenter Christ, MD
role: Principal Investigator
affiliation: Kaiser Franz Josef Hospital
facility: 
country: Austria
url: http://clinicaltrials.gov/ct2/show/NCT01515345
description: IDEAL-PCI Registry
responsible party type: Principal Investigator
investigator affiliation: Kaiser Franz Josef Hospital
investigator full name: Prof. Dr. Guenter Christ
investigator title: Prof
mesh term: Arteriosclerosis
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia