<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/NCT01731041</url>
  </required_header>
  <id_info>
    <org_study_id>UFJ 2012-096</org_study_id>
    <nct_id>NCT01731041</nct_id>
  </id_info>
  <brief_title>Impact of Ticagrelor Re-load on Pharmacodynamic Profiles</brief_title>
  <official_title>Impact of Ticagrelor Re-load on Pharmacodynamic Profiles in Patients on Maintenance Ticagrelor Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Platelets are parts of your blood that stick together to help form a clot. The stickier your&#xD;
      platelets are, the greater your chance of having a heart attack. A clot in the wrong place&#xD;
      can lead to a heart attack or stroke. Ticagrelor (Brilinta) keeps platelets from sticking&#xD;
      together and it helps people from having a heart attack. The American College of Cardiology&#xD;
      has recommended a combination of aspirin and Brilinta as one of the best treatments for the&#xD;
      prevention of heart attacks, and death in patients who have had a heart attack or coronary&#xD;
      stents. However, it is unknown if Brilinta may improve its work to keep platelets from&#xD;
      sticking together giving a loading dose in patients already treated with Brilinta. A loading&#xD;
      dose is a one-time increased dose of the same drug. The purpose of this study is to&#xD;
      demonstrate whether the platelets of patients treated with Brilinta become less sticky when&#xD;
      Brilinta is re-loaded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A higher degree of platelet inhibition remains the goal of peri-interventional and long-term&#xD;
      anti-thrombotic therapy in patients with coronary artery disease. Previous observations have&#xD;
      shown that in patients on clopidogrel therapy undergoing percutanoues coronary intervention&#xD;
      who get re-loaded with clopidogrel obtain enhanced platelet inhibition. Ticagrelor represents&#xD;
      a new class of nonthienopyridine platelet inhibitors designed to address the limitations of&#xD;
      current oral antiplatelet therapy, which has been recently approved for clinical use.&#xD;
      However, to date it is unknown if greater inhibition of platelet aggregation can be achieved&#xD;
      by adding a ticagrelor loading dose in patients already on maintenance ticagrelor therapy (90&#xD;
      mg twice daily). In addition, how to manage patients undergoing coronary interventions&#xD;
      already on chronic ticagrelor therapy with regards to ticagrelor loading is an emerging&#xD;
      clinical question which has yet to be explored. Therefore, understanding the pharmacodynamic&#xD;
      implications of a ticagrelor re-load strategy in patients on already on chronic ticagrelor&#xD;
      therapy is warranted. The scope of the present study is to evaluate the impact of ticagrelor&#xD;
      re-load in patients on chronic ticagrelor therapy. A total of 60 patients will be randomized&#xD;
      into one of the following two arms of treatment: 1) 90 mg of ticagrelor; 2) 180 mg of&#xD;
      ticagrelor. Pharmacodynamic assessments will be performed at baseline, 1-hour and 4-hour&#xD;
      after dosing administration. Comparison between baseline and 4-hour values in term of&#xD;
      platelet P2Y12 reactivity index determined by whole blood vasodilator-stimulated&#xD;
      phosphoprotein will be the primary end-point of the study. Secondary endpoints will include&#xD;
      other pharmacodynamic measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP)</measure>
    <time_frame>4 hours</time_frame>
    <description>The primary end-point of the study is the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arm of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12</measure>
    <time_frame>4 hours</time_frame>
    <description>Secondary analysis included the differences of platelet reactivity expressed as P2Y12 reaction units (PRU) in each group using the VerifyNow P2Y12 system.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Ticagrelor 180mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to this arm will be administered 180 mg of ticagrelor (experimental arm, loading dose).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ticagrelor 90mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to this arm will be administered 90 mg dose of ticagrelor (active comparator, standard dose).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ticagrelor 180mg</intervention_name>
    <description>Patients will receive 180 mg of ticagrelor</description>
    <arm_group_label>Ticagrelor 180mg</arm_group_label>
    <other_name>Brilinta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ticagrelor 90mg</intervention_name>
    <description>Patients will receive 90 mg of ticagrelor</description>
    <arm_group_label>Ticagrelor 90mg</arm_group_label>
    <other_name>Brilinta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with a clinical indication to be on ticagrelor therapy (90mg/bid)&#xD;
&#xD;
          2. On treatment with ticagrelor 90mg twice daily for at least 14 days&#xD;
&#xD;
          3. Age between 18 to 80 years&#xD;
&#xD;
          4. On aspirin &lt;100mg/day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of intracranial bleeding&#xD;
&#xD;
          2. Severe hepatic impairment (ALT &gt;2.5 times the upper limit of normal)&#xD;
&#xD;
          3. Active bleeding or propensity to bleed&#xD;
&#xD;
          4. Recent antiplatelet treatment (&lt; 14 days) with a glycoprotein IIb/IIIa antagonist&#xD;
&#xD;
        6. Platelet count &lt;80x106/mL 7. Hemodynamic instability 8. Serum creatinine &lt;30 mL/min 9.&#xD;
        On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban) 10.&#xD;
        Patients with sick sinus syndrome or II or III degree AV block without pacemaker protection&#xD;
        12. Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor):&#xD;
        ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir,&#xD;
        saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin 13. Hemoglobin &lt; 10g/dL&#xD;
        14. Pregnant females [women of childbearing age must use reliable birth control (i.e. oral&#xD;
        contraceptives) while participating in the study].&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominick J Angiolillo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <results_first_submitted>May 6, 2015</results_first_submitted>
  <results_first_submitted_qc>May 26, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 10, 2015</results_first_posted>
  <last_update_submitted>May 26, 2015</last_update_submitted>
  <last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>coronary disease, platelet function, platelet inhibitors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ticagrelor</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were screened at the Division of Cardiology of the University Of Florida College Of Medicine - Jacksonville</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Ticagrelor 180mg</title>
          <description>A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).</description>
        </group>
        <group group_id="P2">
          <title>Ticagrelor 90mg</title>
          <description>A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </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>
      <population>All patients had experienced an ACS and had a guideline-based indication to be on DAPT with aspirin and ticagrelor</population>
      <group_list>
        <group group_id="B1">
          <title>Ticagrelor 180mg</title>
          <description>A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).&#xD;
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).</description>
        </group>
        <group group_id="B2">
          <title>Ticagrelor 90mg</title>
          <description>A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).&#xD;
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </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="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </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>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP)</title>
        <description>The primary end-point of the study is the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arm of treatment</description>
        <time_frame>4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ticagrelor 180mg</title>
            <description>A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).&#xD;
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).</description>
          </group>
          <group group_id="O2">
            <title>Ticagrelor 90mg</title>
            <description>A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).&#xD;
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).</description>
          </group>
        </group_list>
        <measure>
          <title>Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP)</title>
          <description>The primary end-point of the study is the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arm of treatment</description>
          <units>PRI%</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.87" spread="2.1"/>
                    <measurement group_id="O2" value="23.4" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12</title>
        <description>Secondary analysis included the differences of platelet reactivity expressed as P2Y12 reaction units (PRU) in each group using the VerifyNow P2Y12 system.</description>
        <time_frame>4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ticagrelor 180mg</title>
            <description>A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).&#xD;
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).</description>
          </group>
          <group group_id="O2">
            <title>Ticagrelor 90mg</title>
            <description>A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).&#xD;
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).</description>
          </group>
        </group_list>
        <measure>
          <title>P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12</title>
          <description>Secondary analysis included the differences of platelet reactivity expressed as P2Y12 reaction units (PRU) in each group using the VerifyNow P2Y12 system.</description>
          <units>PRU</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" spread="3.01"/>
                    <measurement group_id="O2" value="31.4" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events, including bleeding, bradyarrhythmias, and dyspnea, were recorded up to 24 hours after study completition</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ticagrelor 180mg</title>
          <description>A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).&#xD;
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).</description>
        </group>
        <group group_id="E2">
          <title>Ticagrelor 90mg</title>
          <description>A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).&#xD;
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Dominick J. Angiolillo, MD, PhD-Associate Professor of Medicine Director, Cardiovascular Research</name_or_title>
      <organization>University of Florida College of Medicine-Jacksonville</organization>
      <phone>+1-904-244-3005</phone>
      <email>dominick.angiolillo@jax.ufl.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/NCT01731041
org study id: UFJ 2012-096
nct id: NCT01731041
lead sponsor: 
collaborator: 
has dmc: Yes
Platelets are parts of your blood that stick together to help form a clot. The stickier your
      platelets are, the greater your chance of having a heart attack. A clot in the wrong place
      can lead to a heart attack or stroke. Ticagrelor (Brilinta) keeps platelets from sticking
      together and it helps people from having a heart attack. The American College of Cardiology
      has recommended a combination of aspirin and Brilinta as one of the best treatments for the
      prevention of heart attacks, and death in patients who have had a heart attack or coronary
      stents. However, it is unknown if Brilinta may improve its work to keep platelets from
      sticking together giving a loading dose in patients already treated with Brilinta. A loading
      dose is a one-time increased dose of the same drug. The purpose of this study is to
      demonstrate whether the platelets of patients treated with Brilinta become less sticky when
      Brilinta is re-loaded.
A higher degree of platelet inhibition remains the goal of peri-interventional and long-term
      anti-thrombotic therapy in patients with coronary artery disease. Previous observations have
      shown that in patients on clopidogrel therapy undergoing percutanoues coronary intervention
      who get re-loaded with clopidogrel obtain enhanced platelet inhibition. Ticagrelor represents
      a new class of nonthienopyridine platelet inhibitors designed to address the limitations of
      current oral antiplatelet therapy, which has been recently approved for clinical use.
      However, to date it is unknown if greater inhibition of platelet aggregation can be achieved
      by adding a ticagrelor loading dose in patients already on maintenance ticagrelor therapy (90
      mg twice daily). In addition, how to manage patients undergoing coronary interventions
      already on chronic ticagrelor therapy with regards to ticagrelor loading is an emerging
      clinical question which has yet to be explored. Therefore, understanding the pharmacodynamic
      implications of a ticagrelor re-load strategy in patients on already on chronic ticagrelor
      therapy is warranted. The scope of the present study is to evaluate the impact of ticagrelor
      re-load in patients on chronic ticagrelor therapy. A total of 60 patients will be randomized
      into one of the following two arms of treatment: 1) 90 mg of ticagrelor; 2) 180 mg of
      ticagrelor. Pharmacodynamic assessments will be performed at baseline, 1-hour and 4-hour
      after dosing administration. Comparison between baseline and 4-hour values in term of
      platelet P2Y12 reactivity index determined by whole blood vasodilator-stimulated
      phosphoprotein will be the primary end-point of the study. Secondary endpoints will include
      other pharmacodynamic measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP)
time frame: 4 hours
description: The primary end-point of the study is the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arm of treatment
measure: P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12
time frame: 4 hours
description: Secondary analysis included the differences of platelet reactivity expressed as P2Y12 reaction units (PRU) in each group using the VerifyNow P2Y12 system.
arm group label: Ticagrelor 180mg
arm group type: Experimental
description: Patients randomized to this arm will be administered 180 mg of ticagrelor (experimental arm, loading dose).
arm group label: Ticagrelor 90mg
arm group type: Active Comparator
description: Patients randomized to this arm will be administered 90 mg dose of ticagrelor (active comparator, standard dose).
intervention type: Drug
intervention name: Ticagrelor 180mg
description: Patients will receive 180 mg of ticagrelor
arm group label: Ticagrelor 180mg
other name: Brilinta
intervention type: Drug
intervention name: Ticagrelor 90mg
description: Patients will receive 90 mg of ticagrelor
arm group label: Ticagrelor 90mg
other name: Brilinta
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Dominick J Angiolillo, MD, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Ticagrelor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 