<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/NCT03043274</url>
  </required_header>
  <id_info>
    <org_study_id>16-0990-F6A</org_study_id>
    <nct_id>NCT03043274</nct_id>
  </id_info>
  <brief_title>Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size</brief_title>
  <official_title>Periprocedural Cangrelor in Patients With ST-Elevation Myocardial Infarction to Reduce Development of Myocardial Necrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khaled Ziada, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in&#xD;
      patients with ST-elevation myocardial infarction randomized to receive cangrelor during their&#xD;
      percutaneous coronary intervention and compares them to patients randomized to not receive&#xD;
      cangrelor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cangrelor is a direct-acting and reversible intravenously administered platelet inhibitor&#xD;
      approved as an adjunct to percutaneous intervention (PCI) for reducing the risk of&#xD;
      periprocedural myocardial infarction, repeat coronary revascularization, and stent&#xD;
      thrombosis. As it has a quick onset of action (2 minutes) compared to traditional oral&#xD;
      platelet inhibitors, cangrelor is emerging as an important new option for use in patients&#xD;
      undergoing percutaneous intervention who have not been treated with oral platelet inhibitors.&#xD;
&#xD;
      Furthermore, multiple studies have demonstrated that patients with ST-elevation myocardial&#xD;
      infarction (STEMI) who undergo emergent PCI do not have optimal platelet inhibition even&#xD;
      after administration of a loading dose of traditional oral platelet inhibitors. However, the&#xD;
      clinical significance of complete platelet inhibition around the time of PCI is not fully&#xD;
      understood.&#xD;
&#xD;
      The primary objective is to characterize the utility of immediate platelet inhibition with&#xD;
      intravenous cangrelor in patients presenting with an acute STEMI by assessing the extent of&#xD;
      infarct size (either enzymatically or by imaging). If the findings are favorable, this may&#xD;
      suggest that immediate platelet inhibition is an important part of care in this patient&#xD;
      population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Myocardial Infarction Size</measure>
    <time_frame>48 hours and 3 months</time_frame>
    <description>Cardiac MRI is obtained at 48 hours and 3 months to compare differences in infarct size. The outcome is assessed as the difference in infarct size between 48 hours and 3 months in each group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Platelet Reactivity</measure>
    <time_frame>10 minutes</time_frame>
    <description>Platelet reactivity testing will be performed 10 minutes after infusion has started.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral Blood Count Quantification</measure>
    <time_frame>6 hours</time_frame>
    <description>Flow cytometry on peripheral blood will be performed to quantify peripheral counts of inflammatory cells, stem cells, and monocyte subtypes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interferon (IFN)-α2</measure>
    <time_frame>6 hours</time_frame>
    <description>ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-6 in pg/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IFN-γ</measure>
    <time_frame>6 hours</time_frame>
    <description>ELISA assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macrophage-derived Chemokine</measure>
    <time_frame>6 hours</time_frame>
    <description>ELISA assay macrophage-derived chemokine</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>STEMI - ST Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Cangrelor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Approximately 30 patients in this arm will receive standard STEMI care but will also receive standard dosing of cangrelor at the time of their PCI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No cangrelor</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Approximately 30 patients in this arm will receive standard STEMI but will not receive cangrelor at the time of their PCI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cangrelor</intervention_name>
    <description>Cangrelor 30 mcg/kg bolus followed by a 4 mcg/kg/min intravenous infusion prior to PCI will be given. It will be continued for ≥ 2 hours or for the duration of the procedure, whichever is longer.</description>
    <arm_group_label>Cangrelor</arm_group_label>
    <other_name>Kengreal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an acute STEMI with the University of Kentucky as the institution of&#xD;
             presentation with plans for PCI&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Patients who are unable to provide his/her own consent&#xD;
&#xD;
          -  Patients with a prior history of myocardial infarction&#xD;
&#xD;
          -  Patients who have received thrombolytics&#xD;
&#xD;
          -  Patients on systemic anticoagulation&#xD;
&#xD;
          -  Patients who are hemodynamically unstable with evidence of shock&#xD;
&#xD;
          -  Patients who are mechanically intubated&#xD;
&#xD;
          -  Patients with devices not MRI compatible&#xD;
&#xD;
          -  Patients with chronic kidney disease, glomerular filtration rate less than 30&#xD;
&#xD;
          -  Patients who are already on dual antiplatelet therapy&#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>Khaled Ziada, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.kengreal.com/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Keating GM. Cangrelor: A Review in Percutaneous Coronary Intervention. Drugs. 2015 Aug;75(12):1425-34. doi: 10.1007/s40265-015-0445-3.</citation>
    <PMID>26201463</PMID>
  </reference>
  <reference>
    <citation>Johnson TW, Mumford AD, Scott LJ, Mundell S, Butler M, Strange JW, Rogers CA, Reeves BC, Baumbach A. A Study of Platelet Inhibition, Using a 'Point of Care' Platelet Function Test, following Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction [PINPOINT-PPCI]. PLoS One. 2015 Dec 16;10(12):e0144984. doi: 10.1371/journal.pone.0144984. eCollection 2015.</citation>
    <PMID>26672598</PMID>
  </reference>
  <reference>
    <citation>Parodi G, Valenti R, Bellandi B, Migliorini A, Marcucci R, Comito V, Carrabba N, Santini A, Gensini GF, Abbate R, Antoniucci D. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol. 2013 Apr 16;61(15):1601-6. doi: 10.1016/j.jacc.2013.01.024. Epub 2013 Mar 22.</citation>
    <PMID>23500251</PMID>
  </reference>
  <reference>
    <citation>Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schomig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030.</citation>
    <PMID>19264241</PMID>
  </reference>
  <reference>
    <citation>Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH, Ochala A, Carlton TW, Cristea E, Wolff SD, Brener SJ, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Karwoski T, Dizon JM, Mehran R, Gibson CM; INFUSE-AMI Investigators. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA. 2012 May 2;307(17):1817-26. doi: 10.1001/jama.2012.421. Epub 2012 Mar 25.</citation>
    <PMID>22447888</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <results_first_submitted>April 27, 2020</results_first_submitted>
  <results_first_submitted_qc>June 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 30, 2020</results_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Khaled Ziada, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cangrelor</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>December 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03043274/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were recruited in the cardiac catheterization laboratory.</recruitment_details>
      <pre_assignment_details>Patients were randomized upon recruitment to the standard of care alone or standard of care in addition to cangrelor</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cangrelor</title>
          <description>Patients received standard of care in addition to cangrelor with a dose of 30 mcg/kg bolus followed by a 4 mcg/kg/min intravenous infusion, started prior to PPCI, and continued for 2 hours or for the duration of the procedure, whichever is longer.</description>
        </group>
        <group group_id="P2">
          <title>No Cangrelor</title>
          <description>This arm received standard of care alone</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13">The study was terminated because of slow recruitment.</participants>
                <participants group_id="P2" count="9">The study was terminated because of slow recruitment.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cangrelor</title>
          <description>The final subject count in this arm is 13.</description>
        </group>
        <group group_id="B2">
          <title>No Cangrelor</title>
          <description>The final subject number in this arm is 9.</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="13"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="22"/>
          </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="58.9" spread="10.7"/>
                    <measurement group_id="B2" value="57.4" spread="7.7"/>
                    <measurement group_id="B3" value="58.2" spread="9.2"/>
                  </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="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="16"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.8" spread="2"/>
                    <measurement group_id="B2" value="31.6" spread="8.1"/>
                    <measurement group_id="B3" value="29.96" spread="7.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hyperlipidemia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peripehral vascular disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>No prior platelet therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Myocardial Infarction Size</title>
        <description>Cardiac MRI is obtained at 48 hours and 3 months to compare differences in infarct size. The outcome is assessed as the difference in infarct size between 48 hours and 3 months in each group.</description>
        <time_frame>48 hours and 3 months</time_frame>
        <population>standard of care alone vs. Standard of care in addition to cangrelor</population>
        <group_list>
          <group group_id="O1">
            <title>Cangrelor</title>
            <description>The final subject count in this arm is 13.</description>
          </group>
          <group group_id="O2">
            <title>No Cangrelor</title>
            <description>The final subject number in this arm is 9.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Myocardial Infarction Size</title>
          <description>Cardiac MRI is obtained at 48 hours and 3 months to compare differences in infarct size. The outcome is assessed as the difference in infarct size between 48 hours and 3 months in each group.</description>
          <population>standard of care alone vs. Standard of care in addition to cangrelor</population>
          <units>percent of left ventricular mass</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="1.6"/>
                    <measurement group_id="O2" value="11.1" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="1.5"/>
                    <measurement group_id="O2" value="6.98" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Platelet Reactivity</title>
        <description>Platelet reactivity testing will be performed 10 minutes after infusion has started.</description>
        <time_frame>10 minutes</time_frame>
        <population>standard of care alone vs. Standard of care in addition to cangrelor</population>
        <group_list>
          <group group_id="O1">
            <title>Cangrelor</title>
            <description>The final subject count in this arm is 13.</description>
          </group>
          <group group_id="O2">
            <title>No Cangrelor</title>
            <description>The final subject number in this arm is 9.</description>
          </group>
        </group_list>
        <measure>
          <title>Platelet Reactivity</title>
          <description>Platelet reactivity testing will be performed 10 minutes after infusion has started.</description>
          <population>standard of care alone vs. Standard of care in addition to cangrelor</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADP-induced aggregation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.2" spread="24.88"/>
                    <measurement group_id="O2" value="333.4" spread="63.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TRAP-induced aggregation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="285.8" spread="86.1"/>
                    <measurement group_id="O2" value="624.8" spread="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peripheral Blood Count Quantification</title>
        <description>Flow cytometry on peripheral blood will be performed to quantify peripheral counts of inflammatory cells, stem cells, and monocyte subtypes.</description>
        <time_frame>6 hours</time_frame>
        <population>standard of care alone vs. Standard of care in addition to cangrelor</population>
        <group_list>
          <group group_id="O1">
            <title>Cangrelor</title>
            <description>The final subject count in this arm is 13.</description>
          </group>
          <group group_id="O2">
            <title>No Cangrelor</title>
            <description>The final subject number in this arm is 9.</description>
          </group>
        </group_list>
        <measure>
          <title>Peripheral Blood Count Quantification</title>
          <description>Flow cytometry on peripheral blood will be performed to quantify peripheral counts of inflammatory cells, stem cells, and monocyte subtypes.</description>
          <population>standard of care alone vs. Standard of care in addition to cangrelor</population>
          <units>cells per microliter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>granulocyte platelet aggregates</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1166.7" spread="190.7"/>
                    <measurement group_id="O2" value="2550.4" spread="533.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocyte-platelet aggregate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.8" spread="31.1"/>
                    <measurement group_id="O2" value="333.9" spread="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Interferon (IFN)-α2</title>
        <description>ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-6 in pg/mL.</description>
        <time_frame>6 hours</time_frame>
        <population>Plasma level</population>
        <group_list>
          <group group_id="O1">
            <title>Cangrelor</title>
            <description>The final subject count in this arm is 13.</description>
          </group>
          <group group_id="O2">
            <title>No Cangrelor</title>
            <description>The final subject number in this arm is 9.</description>
          </group>
        </group_list>
        <measure>
          <title>Interferon (IFN)-α2</title>
          <description>ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-6 in pg/mL.</description>
          <population>Plasma level</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.2" spread="5.9"/>
                    <measurement group_id="O2" value="57.8" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IFN-γ</title>
        <description>ELISA assay.</description>
        <time_frame>6 hours</time_frame>
        <population>Plasma levels</population>
        <group_list>
          <group group_id="O1">
            <title>Cangrelor</title>
            <description>The final subject count in this arm is 13.</description>
          </group>
          <group group_id="O2">
            <title>No Cangrelor</title>
            <description>The final subject number in this arm is 9.</description>
          </group>
        </group_list>
        <measure>
          <title>IFN-γ</title>
          <description>ELISA assay.</description>
          <population>Plasma levels</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.4" spread="8.5"/>
                    <measurement group_id="O2" value="103.3" spread="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Macrophage-derived Chemokine</title>
        <description>ELISA assay macrophage-derived chemokine</description>
        <time_frame>6 hours</time_frame>
        <population>plasma levels</population>
        <group_list>
          <group group_id="O1">
            <title>Cangrelor</title>
            <description>The final subject count in this arm is 13.</description>
          </group>
          <group group_id="O2">
            <title>No Cangrelor</title>
            <description>The final subject number in this arm is 9.</description>
          </group>
        </group_list>
        <measure>
          <title>Macrophage-derived Chemokine</title>
          <description>ELISA assay macrophage-derived chemokine</description>
          <population>plasma levels</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="593.3" spread="44"/>
                    <measurement group_id="O2" value="873.8" spread="63.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>48 hours</time_frame>
      <desc>bleeding</desc>
      <group_list>
        <group group_id="E1">
          <title>Cangrelor</title>
          <description>The final subject count in this arm is 13.</description>
        </group>
        <group group_id="E2">
          <title>No Cangrelor</title>
          <description>The final subject number in this arm is 9.</description>
        </group>
      </group_list>
      <serious_events>
        <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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated because of slow recruitment.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Khaled M. Ziada</name_or_title>
      <organization>University of Kentucky</organization>
      <phone>8593236036</phone>
      <email>khaled.ziada@uky.edu</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/NCT03043274
org study id: 16-0990-F6A
nct id: NCT03043274
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in
      patients with ST-elevation myocardial infarction randomized to receive cangrelor during their
      percutaneous coronary intervention and compares them to patients randomized to not receive
      cangrelor.
Cangrelor is a direct-acting and reversible intravenously administered platelet inhibitor
      approved as an adjunct to percutaneous intervention (PCI) for reducing the risk of
      periprocedural myocardial infarction, repeat coronary revascularization, and stent
      thrombosis. As it has a quick onset of action (2 minutes) compared to traditional oral
      platelet inhibitors, cangrelor is emerging as an important new option for use in patients
      undergoing percutaneous intervention who have not been treated with oral platelet inhibitors.

      Furthermore, multiple studies have demonstrated that patients with ST-elevation myocardial
      infarction (STEMI) who undergo emergent PCI do not have optimal platelet inhibition even
      after administration of a loading dose of traditional oral platelet inhibitors. However, the
      clinical significance of complete platelet inhibition around the time of PCI is not fully
      understood.

      The primary objective is to characterize the utility of immediate platelet inhibition with
      intravenous cangrelor in patients presenting with an acute STEMI by assessing the extent of
      infarct size (either enzymatically or by imaging). If the findings are favorable, this may
      suggest that immediate platelet inhibition is an important part of care in this patient
      population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Myocardial Infarction Size
time frame: 48 hours and 3 months
description: Cardiac MRI is obtained at 48 hours and 3 months to compare differences in infarct size. The outcome is assessed as the difference in infarct size between 48 hours and 3 months in each group.
measure: Platelet Reactivity
time frame: 10 minutes
description: Platelet reactivity testing will be performed 10 minutes after infusion has started.
measure: Peripheral Blood Count Quantification
time frame: 6 hours
description: Flow cytometry on peripheral blood will be performed to quantify peripheral counts of inflammatory cells, stem cells, and monocyte subtypes.
measure: Interferon (IFN)-α2
time frame: 6 hours
description: ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-6 in pg/mL.
measure: IFN-γ
time frame: 6 hours
description: ELISA assay.
measure: Macrophage-derived Chemokine
time frame: 6 hours
description: ELISA assay macrophage-derived chemokine
arm group label: Cangrelor
arm group type: Experimental
description: Approximately 30 patients in this arm will receive standard STEMI care but will also receive standard dosing of cangrelor at the time of their PCI.
arm group label: No cangrelor
arm group type: No Intervention
description: Approximately 30 patients in this arm will receive standard STEMI but will not receive cangrelor at the time of their PCI.
intervention type: Drug
intervention name: Cangrelor
description: Cangrelor 30 mcg/kg bolus followed by a 4 mcg/kg/min intravenous infusion prior to PCI will be given. It will be continued for ≥ 2 hours or for the duration of the procedure, whichever is longer.
arm group label: Cangrelor
other name: Kengreal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Khaled Ziada, MD
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
url: http://www.kengreal.com/
description: Related Info
citation: Keating GM. Cangrelor: A Review in Percutaneous Coronary Intervention. Drugs. 2015 Aug;75(12):1425-34. doi: 10.1007/s40265-015-0445-3.
PMID: 26201463
citation: Johnson TW, Mumford AD, Scott LJ, Mundell S, Butler M, Strange JW, Rogers CA, Reeves BC, Baumbach A. A Study of Platelet Inhibition, Using a 'Point of Care' Platelet Function Test, following Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction [PINPOINT-PPCI]. PLoS One. 2015 Dec 16;10(12):e0144984. doi: 10.1371/journal.pone.0144984. eCollection 2015.
PMID: 26672598
citation: Parodi G, Valenti R, Bellandi B, Migliorini A, Marcucci R, Comito V, Carrabba N, Santini A, Gensini GF, Abbate R, Antoniucci D. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol. 2013 Apr 16;61(15):1601-6. doi: 10.1016/j.jacc.2013.01.024. Epub 2013 Mar 22.
PMID: 23500251
citation: Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schomig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030.
PMID: 19264241
citation: Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH, Ochala A, Carlton TW, Cristea E, Wolff SD, Brener SJ, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Karwoski T, Dizon JM, Mehran R, Gibson CM; INFUSE-AMI Investigators. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA. 2012 May 2;307(17):1817-26. doi: 10.1001/jama.2012.421. Epub 2012 Mar 25.
PMID: 22447888
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Khaled Ziada, MD
investigator title: Principal Investigator
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
mesh term: Cangrelor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated because of slow recruitment.
point of contact: 