<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/NCT02244710</url>
  </required_header>
  <id_info>
    <org_study_id>ISSBRIL0205</org_study_id>
    <secondary_id>2013-005042-11</secondary_id>
    <nct_id>NCT02244710</nct_id>
  </id_info>
  <brief_title>EndoTic - Endothelium and Ticagrelor</brief_title>
  <official_title>EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Investigación Sanitaria en León</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación Investigación Sanitaria en León</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel&#xD;
      in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells)&#xD;
      in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1&#xD;
      month).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ACS Patients in both treatment groups will be assessed:&#xD;
&#xD;
      Baseline, 48h and 1 month cell counts will be done for CECs and EPCs Platelet Function at 48h&#xD;
      and 1month Adverse Events, ECG and blood testing result will be also collected&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cells</measure>
    <time_frame>Baseline</time_frame>
    <description>EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cells</measure>
    <time_frame>48 hours after last chest pain episode</time_frame>
    <description>EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cells</measure>
    <time_frame>1 month visit</time_frame>
    <description>EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Platelet reactivity</measure>
    <time_frame>At the time of coronary angiography</time_frame>
    <description>As determined by P2Y12 kits, VerifyNow®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet reactivity</measure>
    <time_frame>1 month visit</time_frame>
    <description>As determined by P2Y12 kits, VerifyNow®</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety: Bleeding and ischemic adverse events</measure>
    <time_frame>18 months (Study duration)</time_frame>
    <description>Adverse Events collection</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Acute Coronary Syndrome (ACS)</condition>
  <arm_group>
    <arm_group_label>Ticagrelor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>180mg initial dose next day 90mg BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clopidogrel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>600mg po initial dose and 75mg qd starting next day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ticagrelor vs Clopidogrel</intervention_name>
    <arm_group_label>Clopidogrel</arm_group_label>
    <arm_group_label>Ticagrelor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to sign Informed Consent Form&#xD;
&#xD;
          -  18 yr or older&#xD;
&#xD;
          -  Male and female (post menopause or contraception treatment)&#xD;
&#xD;
          -  ACS diagnosed with elevation of myocardial infarction biomarkers (as of 3rd Universal&#xD;
             Definition of MI)&#xD;
&#xD;
          -  Planned invasive strategy (coronariography performed within 72hrs after admission)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aspirin, clopidogrel or ticagrelor allergy.&#xD;
&#xD;
          -  Hemorrhagic diathesis or very high risk of bleeding.&#xD;
&#xD;
          -  Current treatment with oral anticoagulants, thienopyridines or ticagrelor.&#xD;
&#xD;
          -  Limited life expectancy.&#xD;
&#xD;
          -  Elective surgery planned.&#xD;
&#xD;
          -  High chance of not being able to complete the follow-up period.&#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>Armando Pérez de Prado, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación Investigación Sanitaria en León</affiliation>
  </overall_official>
  <overall_official>
    <last_name>M. Belen Vidriales Acosta, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Salamanca</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario de Santiago</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>La Coruña</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Leon</name>
      <address>
        <city>Leon</city>
        <zip>24008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Circulating Endothelial Cells</keyword>
  <keyword>Endothelial Progenitor Cells</keyword>
  <keyword>Acute coronary syndrome (ACS)</keyword>
  <keyword>Ticagrelor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</mesh_term>
    <mesh_term>Ticagrelor</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/NCT02244710
org study id: ISSBRIL0205
secondary id: 2013-005042-11
nct id: NCT02244710
lead sponsor: 
collaborator: 
has dmc: No
Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel
      in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells)
      in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1
      month).
ACS Patients in both treatment groups will be assessed:

      Baseline, 48h and 1 month cell counts will be done for CECs and EPCs Platelet Function at 48h
      and 1month Adverse Events, ECG and blood testing result will be also collected
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of cells
time frame: Baseline
description: EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
measure: Number of cells
time frame: 48 hours after last chest pain episode
description: EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
measure: Number of cells
time frame: 1 month visit
description: EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
measure: Platelet reactivity
time frame: At the time of coronary angiography
description: As determined by P2Y12 kits, VerifyNow®
measure: Platelet reactivity
time frame: 1 month visit
description: As determined by P2Y12 kits, VerifyNow®
measure: Safety: Bleeding and ischemic adverse events
time frame: 18 months (Study duration)
description: Adverse Events collection
arm group label: Ticagrelor
arm group type: Experimental
description: 180mg initial dose next day 90mg BID
arm group label: Clopidogrel
arm group type: Active Comparator
description: 600mg po initial dose and 75mg qd starting next day
intervention type: Drug
intervention name: Ticagrelor vs Clopidogrel
arm group label: Clopidogrel
arm group label: Ticagrelor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Armando Pérez de Prado, MD, PhD
role: Principal Investigator
affiliation: Fundación Investigación Sanitaria en León
last name: M. Belen Vidriales Acosta, MD, PhD
role: Study Director
affiliation: University of Salamanca
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Clopidogrel
mesh term: Ticagrelor