<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/NCT03772613</url>
  </required_header>
  <id_info>
    <org_study_id>18-005209</org_study_id>
    <nct_id>NCT03772613</nct_id>
  </id_info>
  <brief_title>The Randomized OPTIMAL-ACT Trial</brief_title>
  <official_title>Optimal Target of Activated Clotting Time During Percutaneous Coronary Intervention and Outcomes: The Randomized OPTIMAL-ACT Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo 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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find the ideal range of the activated clotting time (ACT)&#xD;
      during percutaneous coronary intervention (PCI) that is associated with lowering the rate of&#xD;
      undesirable medical outcomes&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Actual">October 25, 2021</completion_date>
  <primary_completion_date type="Actual">October 25, 2021</primary_completion_date>
  <phase>Phase 2</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bleeding</measure>
    <time_frame>From date of randomization until the date of first documented bleeding event up to 24 hours</time_frame>
    <description>Number of subjects to experience bleeding defined as Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Clinical Events</measure>
    <time_frame>30 days</time_frame>
    <description>Number of subjects to experience a Net Adverse Clinical Event (NACE) defined as all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stent Thrombosis</measure>
    <time_frame>30 days</time_frame>
    <description>Number of subjects to experience stent thrombosis</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Ischemic Heart Disease</condition>
  <condition>Anticoagulant-induced Bleeding</condition>
  <condition>Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Low ACT Target</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium ACT Target</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High ACT Target</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Unfractionated heparin</intervention_name>
    <description>Administration of unfractionated heparin will be assessed using the activated clotting time</description>
    <arm_group_label>High ACT Target</arm_group_label>
    <arm_group_label>Low ACT Target</arm_group_label>
    <arm_group_label>Medium ACT Target</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;18&#xD;
&#xD;
          -  Referred for coronary angiography with possible coronary revascularization or&#xD;
             adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receipt of LMWH at treatment dose (not DVT prophylaxis dose) within 6 hours of&#xD;
             coronary angiography&#xD;
&#xD;
          -  Prior GP IIb/IIIa use within the previous 72 hours&#xD;
&#xD;
          -  Use of warfarin (vitamin K antagonist) or direct oral anticoagulant&#xD;
&#xD;
          -  Patients on LMWH bridging strategy&#xD;
&#xD;
          -  PCI within prior 30 days&#xD;
&#xD;
          -  Planned use of bivalirudin as the procedural anticoagulant&#xD;
&#xD;
          -  Rotational atherectomy&#xD;
&#xD;
          -  Excimer laser coronary angioplasty&#xD;
&#xD;
          -  Chronic total occlusions&#xD;
&#xD;
          -  Patients with active bleeding disorders or bleeding diathesis&#xD;
&#xD;
          -  Patients with ST-segment elevation myocardial infarction&#xD;
&#xD;
          -  Patient with clinical evidence of cardiogenic shock (defined as SBP&lt;90 mmHg for ≥30&#xD;
             min OR support to maintain SBP ≥90 mmHg AND evidence of end-organ hypoperfusion (urine&#xD;
             output &lt;30 mL/h or cool extremities)&#xD;
&#xD;
          -  Chronic kidney disease stage 4/5 (GFR 30 mL/min)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shahyar M Gharacholou, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <results_first_submitted>March 8, 2023</results_first_submitted>
  <results_first_submitted_qc>March 8, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 4, 2023</results_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Shahyar M. Gharacholou</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>activated clotting time</keyword>
  <keyword>outcomes</keyword>
  <keyword>bleeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Calcium heparin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03772613/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Low ACT Target</title>
          <description>ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
        </group>
        <group group_id="P2">
          <title>Medium ACT Target</title>
          <description>ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
        </group>
        <group group_id="P3">
          <title>High ACT Target</title>
          <description>ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Low ACT Target</title>
          <description>ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
        </group>
        <group group_id="B2">
          <title>Medium ACT Target</title>
          <description>ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
        </group>
        <group group_id="B3">
          <title>High ACT Target</title>
          <description>ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
        </group>
        <group group_id="B4">
          <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="61"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="58"/>
            <count group_id="B4" value="180"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="61"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="58"/>
                    <count group_id="B4" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66" spread="12"/>
                    <measurement group_id="B2" value="68" spread="10"/>
                    <measurement group_id="B3" value="67" spread="10"/>
                    <measurement group_id="B4" value="67" spread="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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="61"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="58"/>
                    <count group_id="B4" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" 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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="61"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="58"/>
                    <count group_id="B4" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="58"/>
                    <measurement group_id="B4" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bleeding</title>
        <description>Number of subjects to experience bleeding defined as Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V)</description>
        <time_frame>From date of randomization until the date of first documented bleeding event up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low ACT Target</title>
            <description>ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
          </group>
          <group group_id="O2">
            <title>Medium ACT Target</title>
            <description>ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
          </group>
          <group group_id="O3">
            <title>High ACT Target</title>
            <description>ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
          </group>
        </group_list>
        <measure>
          <title>Bleeding</title>
          <description>Number of subjects to experience bleeding defined as Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adverse Clinical Events</title>
        <description>Number of subjects to experience a Net Adverse Clinical Event (NACE) defined as all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low ACT Target</title>
            <description>ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
          </group>
          <group group_id="O2">
            <title>Medium ACT Target</title>
            <description>ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
          </group>
          <group group_id="O3">
            <title>High ACT Target</title>
            <description>ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Clinical Events</title>
          <description>Number of subjects to experience a Net Adverse Clinical Event (NACE) defined as all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stent Thrombosis</title>
        <description>Number of subjects to experience stent thrombosis</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low ACT Target</title>
            <description>ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
          </group>
          <group group_id="O2">
            <title>Medium ACT Target</title>
            <description>ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
          </group>
          <group group_id="O3">
            <title>High ACT Target</title>
            <description>ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
          </group>
        </group_list>
        <measure>
          <title>Stent Thrombosis</title>
          <description>Number of subjects to experience stent thrombosis</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from baseline to end of study participation for a total of approximately one month on all participants.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Low ACT Target</title>
          <description>ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
        </group>
        <group group_id="E2">
          <title>Medium ACT Target</title>
          <description>ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</description>
        </group>
        <group group_id="E3">
          <title>High ACT Target</title>
          <description>ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used&#xD;
Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time</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="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="4" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Vessel Closure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Dissection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Spasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </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>Dr. Shahyar M. Gharacholou</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>904-956-8400</phone>
      <email>Gharacholou.Shahyar@mayo.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/NCT03772613
org study id: 18-005209
nct id: NCT03772613
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to find the ideal range of the activated clotting time (ACT)
      during percutaneous coronary intervention (PCI) that is associated with lowering the rate of
      undesirable medical outcomes
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Bleeding
time frame: From date of randomization until the date of first documented bleeding event up to 24 hours
description: Number of subjects to experience bleeding defined as Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V)
measure: Adverse Clinical Events
time frame: 30 days
description: Number of subjects to experience a Net Adverse Clinical Event (NACE) defined as all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding
measure: Stent Thrombosis
time frame: 30 days
description: Number of subjects to experience stent thrombosis
arm group label: Low ACT Target
arm group type: Active Comparator
description: ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
arm group label: Medium ACT Target
arm group type: Active Comparator
description: ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
arm group label: High ACT Target
arm group type: Active Comparator
description: ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
intervention type: Drug
intervention name: Unfractionated heparin
description: Administration of unfractionated heparin will be assessed using the activated clotting time
arm group label: High ACT Target
arm group label: Low ACT Target
arm group label: Medium ACT Target
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shahyar M Gharacholou, MD, MSc
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Shahyar M. Gharacholou
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Heart Diseases
mesh term: Hemorrhage
mesh term: Heparin
mesh term: Calcium heparin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 