<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/NCT02230527</url>
  </required_header>
  <id_info>
    <org_study_id>14-799</org_study_id>
    <nct_id>NCT02230527</nct_id>
  </id_info>
  <brief_title>Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia</brief_title>
  <official_title>Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center, prospective, randomized, unblinded, open-label, active controlled&#xD;
      pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus clopidogrel&#xD;
      plus aspirin in patients with Rutherford Stage IV to VI PAD that have undergone a&#xD;
      percutaneous transluminal angioplasty (PTA) of the lower extremities in the past 2 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enrollment into the study will require severe symptomatic CLI without wounds (Rutherford&#xD;
      Stage IV) or CLI with concomitant vascular insufficiency wounds (Rutherford Stage V-VI PAD).&#xD;
&#xD;
      Potential participants will be identified and screened prior to discharge or at the time of&#xD;
      the first out-patient visit (within 2 weeks after discharge) after a percutaneous lower&#xD;
      extremity arterial angiography with arterial intervention (stent or balloon angioplasty) for&#xD;
      the presence of lower extremity vascular insufficiency. Participants will be classified as&#xD;
      Rutherford Class IV - VI (with or without ulcerations). A total of 60 patients will be&#xD;
      randomized into 2 treatment groups in a 1:1 ratio (ticagrelor to clopidogrel). Patients are&#xD;
      placed on clopidogrel after their arterial intervention per standard of care. They will&#xD;
      remain on clopidogrel up to the time that randomization occurs. For patients that are&#xD;
      randomized to ticagrelor, the clopidogrel will be stopped.&#xD;
&#xD;
      Patients will be randomized to either ticagrelor 90mg by mouth twice daily or clopidogrel&#xD;
      75mg by mouth daily.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">May 2020</completion_date>
  <primary_completion_date type="Actual">May 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Change in TcPO2 From Baseline to Month 6</measure>
    <time_frame>6 months</time_frame>
    <description>The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Clopidogrel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Clopidogrel 75mg by mouth daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ticagrelor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ticagrelor 90mg by mouth twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ticagrelor</intervention_name>
    <description>90mg twice a day by mouth</description>
    <arm_group_label>Ticagrelor</arm_group_label>
    <other_name>Brilinta</other_name>
    <other_name>Brilique</other_name>
    <other_name>Possia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <description>75mg once a day by mouth</description>
    <arm_group_label>Clopidogrel</arm_group_label>
    <other_name>Plavix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults age 18-100 years with Rutherford Classification Stage IV through VI PAD with a&#xD;
             recent percutaneous lower extremity arterial angiography with arterial intervention in&#xD;
             the past 2 weeks&#xD;
&#xD;
          2. Willingness to sign informed consent&#xD;
&#xD;
          3. Ability to return for follow up visits&#xD;
&#xD;
          4. A female patient of childbearing potential who is sexually active must agree to use&#xD;
             adequate contraception from screening until 30 days after receiving the last dose of&#xD;
             study drug. Women not of childbearing potential are defined as those who have&#xD;
             surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who&#xD;
             are post menopausal (defined as at least 2 years since last regular menses). The&#xD;
             female patient should not be lactating and must have a negative pregnancy test at&#xD;
             screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be ineligible for this study if they meet any one of the following criteria:&#xD;
&#xD;
          1. Intolerance to thienopyridines&#xD;
&#xD;
          2. Hypersensitivity to ticagrelor or any component of the product.&#xD;
&#xD;
          3. Concomitant use of oral anticoagulation with vitamin K antagonist, factor Xa&#xD;
             inhibitor, or direct thrombin inhibitor&#xD;
&#xD;
          4. History of intracranial hemorrhage&#xD;
&#xD;
          5. History of severe hepatic impairment defined by baseline transaminase greater than or&#xD;
             equal to 3x ULN or any elevation in bilirubin&#xD;
&#xD;
          6. Active bleeding&#xD;
&#xD;
          7. Allergy to aspirin&#xD;
&#xD;
          8. Baseline TcPO2 &lt; 10 mmHg post angiography&#xD;
&#xD;
          9. Resting, pre- procedure heart rate &lt;50 beats-per-minute without a permanent pacemaker&#xD;
             and not on an atrioventricular nodal blocking agent&#xD;
&#xD;
         10. Severe COPD on home oxygen therapy -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Campbell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <results_first_submitted>June 15, 2021</results_first_submitted>
  <results_first_submitted_qc>June 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 7, 2021</results_first_posted>
  <last_update_submitted>June 15, 2021</last_update_submitted>
  <last_update_submitted_qc>June 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Joseph Campbell</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>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</mesh_term>
    <mesh_term>Ticagrelor</mesh_term>
  </intervention_browse>
  <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>September 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT02230527/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Clopidogrel</title>
          <description>Clopidogrel 75mg by mouth daily&#xD;
Clopidogrel: 75mg once a day by mouth</description>
        </group>
        <group group_id="P2">
          <title>Ticagrelor</title>
          <description>Ticagrelor 90mg by mouth twice daily&#xD;
Ticagrelor: 90mg twice a day by mouth</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Clopidogrel</title>
          <description>Clopidogrel 75mg by mouth daily&#xD;
Clopidogrel: 75mg once a day by mouth</description>
        </group>
        <group group_id="B2">
          <title>Ticagrelor</title>
          <description>Ticagrelor 90mg by mouth twice daily&#xD;
Ticagrelor: 90mg twice a day by mouth</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="23"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="46"/>
          </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="66.4" spread="11.8"/>
                    <measurement group_id="B2" value="67.2" spread="8.9"/>
                    <measurement group_id="B3" value="66.8" spread="10.3"/>
                  </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="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American/Black</title>
              <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>
          <title>Past/Current Smoker</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Hyperlipidemia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change in TcPO2 From Baseline to Month 6</title>
        <description>The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups.</description>
        <time_frame>6 months</time_frame>
        <population>Patients with baseline and TCPO2 data available at 6 months</population>
        <group_list>
          <group group_id="O1">
            <title>Clopidogrel</title>
            <description>Clopidogrel 75mg by mouth daily&#xD;
Clopidogrel: 75mg once a day by mouth</description>
          </group>
          <group group_id="O2">
            <title>Ticagrelor</title>
            <description>Ticagrelor 90mg by mouth twice daily&#xD;
Ticagrelor: 90mg twice a day by mouth</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in TcPO2 From Baseline to Month 6</title>
          <description>The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups.</description>
          <population>Patients with baseline and TCPO2 data available at 6 months</population>
          <units>mmHG</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" spread="17.8"/>
                    <measurement group_id="O2" value="4.2" spread="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through 6 months</time_frame>
      <desc>Serious adverse events</desc>
      <group_list>
        <group group_id="E1">
          <title>Clopidogrel</title>
          <description>Clopidogrel 75mg by mouth daily&#xD;
Clopidogrel: 75mg once a day by mouth</description>
        </group>
        <group group_id="E2">
          <title>Ticagrelor</title>
          <description>Ticagrelor 90mg by mouth twice daily&#xD;
Ticagrelor: 90mg twice a day by mouth</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="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Stent occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Organ failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Amputation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Worsening Limb Ischemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Limb pain/ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="23"/>
              </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="3" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Junctional rhythm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>UTI</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Kidney stone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Shortness of breath</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Foot ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Excessive bruising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </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>
    <point_of_contact>
      <name_or_title>Joseph Campbell, MD</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>216-444-9836</phone>
      <email>campbej10@ccf.org</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/NCT02230527
org study id: 14-799
nct id: NCT02230527
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a single center, prospective, randomized, unblinded, open-label, active controlled
      pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus clopidogrel
      plus aspirin in patients with Rutherford Stage IV to VI PAD that have undergone a
      percutaneous transluminal angioplasty (PTA) of the lower extremities in the past 2 weeks.
Enrollment into the study will require severe symptomatic CLI without wounds (Rutherford
      Stage IV) or CLI with concomitant vascular insufficiency wounds (Rutherford Stage V-VI PAD).

      Potential participants will be identified and screened prior to discharge or at the time of
      the first out-patient visit (within 2 weeks after discharge) after a percutaneous lower
      extremity arterial angiography with arterial intervention (stent or balloon angioplasty) for
      the presence of lower extremity vascular insufficiency. Participants will be classified as
      Rutherford Class IV - VI (with or without ulcerations). A total of 60 patients will be
      randomized into 2 treatment groups in a 1:1 ratio (ticagrelor to clopidogrel). Patients are
      placed on clopidogrel after their arterial intervention per standard of care. They will
      remain on clopidogrel up to the time that randomization occurs. For patients that are
      randomized to ticagrelor, the clopidogrel will be stopped.

      Patients will be randomized to either ticagrelor 90mg by mouth twice daily or clopidogrel
      75mg by mouth daily.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Absolute Change in TcPO2 From Baseline to Month 6
time frame: 6 months
description: The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups.
arm group label: Clopidogrel
arm group type: Active Comparator
description: Clopidogrel 75mg by mouth daily
arm group label: Ticagrelor
arm group type: Experimental
description: Ticagrelor 90mg by mouth twice daily
intervention type: Drug
intervention name: Ticagrelor
description: 90mg twice a day by mouth
arm group label: Ticagrelor
other name: Brilinta
other name: Brilique
other name: Possia
intervention type: Drug
intervention name: Clopidogrel
description: 75mg once a day by mouth
arm group label: Clopidogrel
other name: Plavix
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Joseph Campbell, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Joseph Campbell
investigator title: Principal Investigator
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia
mesh term: Clopidogrel
mesh term: Ticagrelor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 