<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/NCT03258281</url>
  </required_header>
  <id_info>
    <org_study_id>17-2639</org_study_id>
    <nct_id>NCT03258281</nct_id>
  </id_info>
  <brief_title>Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus</brief_title>
  <acronym>ISS-DMII</acronym>
  <official_title>Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus After Elective Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inova Health Care Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inova Health Care Services</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, single center, double-blind, randomized pharmacodynamic experimental study. The&#xD;
      study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and&#xD;
      Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible&#xD;
      patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2)&#xD;
      placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind randomized clinical trial of evolocumab versus placebo in patients&#xD;
      with ASCVD and DM on clopidogrel and aspirin undergoing PCI. The study is aimed to assess&#xD;
&#xD;
        1. the effect of evolocumab therapy on platelet activation and reactivity;&#xD;
&#xD;
        2. the effect of evolocumab on biomarkers of platelet activation and inflammation.&#xD;
&#xD;
      Eligible patients will be randomized prior to start the PCI equally to either:&#xD;
&#xD;
        1. 420 mg evolocumab ; or&#xD;
&#xD;
        2. placebo. The randomized treatment will be administered in subcutaneous injections.&#xD;
&#xD;
      The laboratory assessments will be performed before (baseline), and 16-24 hours and 30-days&#xD;
      after randomization.&#xD;
&#xD;
      Subject participation will be 30 days from the randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression</measure>
    <time_frame>Baseline and after 30 days of treatment</time_frame>
    <description>Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in ADP-unstimulated P-selectin Expression</measure>
    <time_frame>Baseline and after 30 days of treatment</time_frame>
    <description>Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)</measure>
    <time_frame>Baseline and after 30 days of treatment</time_frame>
    <description>Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI</measure>
    <time_frame>Baseline and after 30 days of treatment</time_frame>
    <description>Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Dyslipidemia Associated With Type II Diabetes Mellitus</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <arm_group>
    <arm_group_label>evolocumab 420mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>75 subjects on optimal statin therapy undergoing elective PCI will receive placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Evolocumab</intervention_name>
    <description>Patients will receive evolocumab 420 mg administered subcutaneously</description>
    <arm_group_label>evolocumab 420mg</arm_group_label>
    <other_name>Repatha</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Patients will receive placebo administered subcutaneously</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes Mellitus&#xD;
&#xD;
          -  Dyslipidemia&#xD;
&#xD;
          -  Undergoing elective PCI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with recent Acute Coronary Syndrome (≤1 month)&#xD;
&#xD;
          -  Patients on dual antiplatelet treatment (DAPT) with ticagrelor or prasugrel&#xD;
&#xD;
          -  Patients undergoing urgent/emergent PCI for stent thrombosis&#xD;
&#xD;
          -  Severe acute or chronic medical or psychiatric condition&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Participation in another experimental clinical trial, without formal approval&#xD;
&#xD;
          -  Unwillingness or inability to comply with the requirements of this protocol&#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>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <results_first_submitted>December 2, 2022</results_first_submitted>
  <results_first_submitted_qc>December 22, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 19, 2023</results_first_posted>
  <last_update_submitted>December 22, 2022</last_update_submitted>
  <last_update_submitted_qc>December 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2023</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Evolocumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03258281/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03258281/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 31 participants were screened, 4 met eligibility and were randomized to the study treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Evolocumab 420mg</title>
          <description>Participants on optimal statin therapy undergoing elective percutaneous coronary intervention (PCI) will receive evolocumab 420mg.&#xD;
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants on optimal statin therapy undergoing elective percutaneous coronary intervention (PCI) will receive placebo&#xD;
Placebo: Participants will receive placebo administered subcutaneously</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Evolocumab 420mg</title>
          <description>Participants on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.&#xD;
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants on optimal statin therapy undergoing elective PCI will receive placebo&#xD;
Placebo: Participants will receive placebo administered subcutaneously</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" spread="8"/>
                    <measurement group_id="B2" value="67" spread="0"/>
                    <measurement group_id="B3" value="69" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression</title>
        <description>Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo).</description>
        <time_frame>Baseline and after 30 days of treatment</time_frame>
        <population>Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.</population>
        <group_list>
          <group group_id="O1">
            <title>Evolocumab 420mg</title>
            <description>Participants on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.&#xD;
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants on optimal statin therapy undergoing elective PCI will receive placebo&#xD;
Placebo: Participants will receive placebo administered subcutaneously</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression</title>
          <description>Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo).</description>
          <population>Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.</population>
          <units>% Positive Cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.2" spread="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.8" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in ADP-unstimulated P-selectin Expression</title>
        <description>Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo)</description>
        <time_frame>Baseline and after 30 days of treatment</time_frame>
        <population>Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.</population>
        <group_list>
          <group group_id="O1">
            <title>Evolocumab 420mg</title>
            <description>Participants on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.&#xD;
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants on optimal statin therapy undergoing elective PCI will receive placebo&#xD;
Placebo: Participants will receive placebo administered subcutaneously</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ADP-unstimulated P-selectin Expression</title>
          <description>Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo)</description>
          <population>Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.</population>
          <units>% Positive Cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)</title>
        <description>Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)</description>
        <time_frame>Baseline and after 30 days of treatment</time_frame>
        <population>Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.</population>
        <group_list>
          <group group_id="O1">
            <title>Evolocumab 420mg</title>
            <description>Participants on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.&#xD;
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants on optimal statin therapy undergoing elective PCI will receive placebo&#xD;
Placebo: Participants will receive placebo administered subcutaneously</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)</title>
          <description>Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)</description>
          <population>Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.</population>
          <units>MFI</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1186" spread="1017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="721" spread="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI</title>
        <description>Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)</description>
        <time_frame>Baseline and after 30 days of treatment</time_frame>
        <population>Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.</population>
        <group_list>
          <group group_id="O1">
            <title>Evolocumab 420mg</title>
            <description>Participants on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.&#xD;
Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants on optimal statin therapy undergoing elective PCI will receive placebo&#xD;
Placebo: Participants will receive placebo administered subcutaneously</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI</title>
          <description>Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)</description>
          <population>Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group.</population>
          <units>MFI</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1459" spread="1220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="678" spread="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 Days</time_frame>
      <desc>Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a drug. This includes any newly occurring event that has increased in severity or frequency since the administration of the study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Evolocumab 420mg</title>
          <description>75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.&#xD;
Evolocumab: Patients will receive evolocumab 420 mg administered subcutaneously</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>75 subjects on optimal statin therapy undergoing elective PCI will receive placebo&#xD;
Placebo: Patients will receive placebo administered subcutaneously</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <description>Chest pain requiring hospitalization</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study was terminated early as a result of 1) low enrollment and , 2) thrombosis research center moving to another health system (LifeBridge Health) . Only 4 patients were enrolled, as a result we were not able to conduct an analysis on any of the endpoints.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Director of Clinical Trials</name_or_title>
      <organization>Sinai Center for Thrombosis Research</organization>
      <phone>443-244-1497</phone>
      <email>kpbliden@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03258281
org study id: 17-2639
nct id: NCT03258281
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Prospective, single center, double-blind, randomized pharmacodynamic experimental study. The
      study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and
      Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible
      patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2)
      placebo.
This is a double-blind randomized clinical trial of evolocumab versus placebo in patients
      with ASCVD and DM on clopidogrel and aspirin undergoing PCI. The study is aimed to assess

        1. the effect of evolocumab therapy on platelet activation and reactivity;

        2. the effect of evolocumab on biomarkers of platelet activation and inflammation.

      Eligible patients will be randomized prior to start the PCI equally to either:

        1. 420 mg evolocumab ; or

        2. placebo. The randomized treatment will be administered in subcutaneous injections.

      The laboratory assessments will be performed before (baseline), and 16-24 hours and 30-days
      after randomization.

      Subject participation will be 30 days from the randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
time frame: Baseline and after 30 days of treatment
description: Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo).
measure: Change in ADP-unstimulated P-selectin Expression
time frame: Baseline and after 30 days of treatment
description: Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo)
measure: Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)
time frame: Baseline and after 30 days of treatment
description: Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
measure: Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI
time frame: Baseline and after 30 days of treatment
description: Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
arm group label: evolocumab 420mg
arm group type: Active Comparator
description: 75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
arm group label: placebo
arm group type: Placebo Comparator
description: 75 subjects on optimal statin therapy undergoing elective PCI will receive placebo
intervention type: Drug
intervention name: Evolocumab
description: Patients will receive evolocumab 420 mg administered subcutaneously
arm group label: evolocumab 420mg
other name: Repatha
intervention type: Drug
intervention name: Placebo
description: Patients will receive placebo administered subcutaneously
arm group label: placebo
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Dyslipidemias
mesh term: Evolocumab
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study was terminated early as a result of 1) low enrollment and , 2) thrombosis research center moving to another health system (LifeBridge Health) . Only 4 patients were enrolled, as a result we were not able to conduct an analysis on any of the endpoints.
point of contact: 