<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/NCT01709981</url>
  </required_header>
  <id_info>
    <org_study_id>11-02573</org_study_id>
    <nct_id>NCT01709981</nct_id>
  </id_info>
  <brief_title>Anti-inflammatory Effects of Colchicine in PCI</brief_title>
  <official_title>Anti-inflammatory Effects of Colchicine in Patients Undergoing Percutaneous Coronary Intervention: Inflammatory Marker Substudy of the Colchicine-PCI Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <brief_summary>
    <textblock>
      Peri-procedural inflammation is associated with increased rates of post-procedural myocardial&#xD;
      infarction (MI), which occur in up to 35% of PCI patients and are themselves associated with&#xD;
      increased risk of later MI and death. Statins suppress both inflammatory markers and MI rates&#xD;
      during and after PCI, but ≥ 40% of PCI patients go statin-untreated, due in part to side&#xD;
      effects such as myalgia. Moreover, because their mechanism of action relies on&#xD;
      post-translational effects, statins must be given ≥ 12 to 24 hours prior to PCI, a time frame&#xD;
      that is not always feasible. The investigators propose a novel alternative approach to reduce&#xD;
      inflammation during PCI employing colchicine, an anti-inflammatory medication used frequently&#xD;
      in gout and pericarditis. Colchicine may be particularly applicable to the PCI setting due to&#xD;
      its rapid onset of action and excellent side-effect profile at low doses, as well as its&#xD;
      known mechanisms of action. However, data on colchicine use in patients with coronary disease&#xD;
      is extremely limited, and no studies to date have evaluated the use of colchicine in patients&#xD;
      undergoing PCI. The investigators aim to characterize a potential mechanism of benefit in&#xD;
      patients undergoing PCI by evaluating the effects of colchicine on soluble and leukocyte&#xD;
      surface markers after PCI. The investigators also aim to determine the effects of colchicine&#xD;
      on peri-procedural myonecrosis and MI. Accordingly, the investigators propose a prospective&#xD;
      randomized study to characterize the effect of colchicine on inflammation and peri-procedural&#xD;
      myocnecrosis. Patients referred for possible PCI will be randomized in a double-blinded&#xD;
      fashion to placebo or colchicine (1.2mg 1 to 2 hours before PCI, followed by 0.6mg 1 hour&#xD;
      later). The primary endpoint will be post-procedural interleukin-6 level. Secondary endpoints&#xD;
      will include other relevant soluble and leukocyte-associated inflammatory markers. Sample&#xD;
      size needed is 200 patients undergoing PCI. To adjust for a floor effect, 280 patients&#xD;
      undergoing PCI will be needed. 400 patients will likely be needed to be enrolled to reach 280&#xD;
      PCIs (the remaining will have undergone a diagnostic only procedure). Of note, this is a&#xD;
      substudy of the COLCHICINE-PCI trial (NCT 02594111)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2013</start_date>
  <completion_date type="Actual">December 13, 2021</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in Post-procedural IL-6 Concentration From Baseline to 30 Min -1 hr After PCI</measure>
    <time_frame>30 minutes to 1 hour after PCI</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Post-procedural IL-6 Concentration From Baseline to 22-24 hr After PCI</measure>
    <time_frame>baseline to 22-24 hr after PCI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Post-procedural hsCRP Concentration From Baseline to 22-24 hr After PCI</measure>
    <time_frame>baseline to 22-24 hr after PCI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI</measure>
    <time_frame>30 minutes to 1 hour after PCI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI</measure>
    <time_frame>baseline to 22-24 hr after PCI</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Colchicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 1-2 hours prior PCI, followed by placebo 1 hour later</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Colchicine</intervention_name>
    <description>Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later</description>
    <arm_group_label>Colchicine</arm_group_label>
    <other_name>Colcrys</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be more than 18 years of age and referred for coronary angiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Plan for diagnostic-only coronary angiography&#xD;
&#xD;
          -  On colchicine chronically&#xD;
&#xD;
          -  History of intolerance to colchicine&#xD;
&#xD;
          -  Glomerular filtration rate &lt;30mL/minute or on dialysis&#xD;
&#xD;
          -  Active malignancy or infection&#xD;
&#xD;
          -  History of myelodysplasia&#xD;
&#xD;
          -  High-dose statin load &lt;24 hours prior to procedure&#xD;
&#xD;
          -  Use of oral steroids or non-steroidal anti-inflammatory agents other than aspirin&#xD;
             within 72 hours or 3 times the agent's half-life (whichever is longer)&#xD;
&#xD;
          -  Use of strong CYP3A4/P-glycoprotein inhibitors (specifically ritonavir, ketoconazole,&#xD;
             clarithromycin, cyclosporine, diltiazem and verapamil)&#xD;
&#xD;
          -  Unable to consent&#xD;
&#xD;
          -  Participating in a competing study&#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>Binita Shah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Manhattan VA Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellevue Hospital Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>July 23, 2020</results_first_submitted>
  <results_first_submitted_qc>August 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 9, 2020</results_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colchicine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT01709981/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT01709981/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Colchicine</title>
          <description>1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later&#xD;
Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo 1-2 hours prior PCI, followed by placebo 1 hour later&#xD;
Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
                <participants group_id="P2" count="139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
                <participants group_id="P2" count="139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Colchicine</title>
          <description>Colchicine</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo</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="141"/>
            <count group_id="B2" value="139"/>
            <count group_id="B3" value="280"/>
          </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="64.31" spread="9.29"/>
                    <measurement group_id="B2" value="65.15" spread="10.38"/>
                    <measurement group_id="B3" value="64.7" spread="9.8"/>
                  </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="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="127"/>
                    <measurement group_id="B3" value="257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="216"/>
                  </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>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="4"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="15"/>
                  </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="32"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="207"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="141"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Post-procedural IL-6 Concentration From Baseline to 30 Min -1 hr After PCI</title>
        <time_frame>30 minutes to 1 hour after PCI</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Colchicine</title>
            <description>1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later&#xD;
Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo 1-2 hours prior PCI, followed by placebo 1 hour later&#xD;
Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Post-procedural IL-6 Concentration From Baseline to 30 Min -1 hr After PCI</title>
          <units>% change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-161" upper_limit="241"/>
                    <measurement group_id="O2" value="20" lower_limit="-99" upper_limit="282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Mann-Whitney</non_inferiority_desc>
            <p_value>0.31</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>2-sided</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Post-procedural IL-6 Concentration From Baseline to 22-24 hr After PCI</title>
        <time_frame>baseline to 22-24 hr after PCI</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Colchicine</title>
            <description>1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later&#xD;
Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo 1-2 hours prior PCI, followed by placebo 1 hour later&#xD;
Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Post-procedural IL-6 Concentration From Baseline to 22-24 hr After PCI</title>
          <units>% change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" lower_limit="-6" upper_limit="898"/>
                    <measurement group_id="O2" value="338" lower_limit="27" upper_limit="1264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Post-procedural hsCRP Concentration From Baseline to 22-24 hr After PCI</title>
        <time_frame>baseline to 22-24 hr after PCI</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Colchicine</title>
            <description>1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later&#xD;
Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo 1-2 hours prior PCI, followed by placebo 1 hour later&#xD;
Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Post-procedural hsCRP Concentration From Baseline to 22-24 hr After PCI</title>
          <units>% change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="-14" upper_limit="80"/>
                    <measurement group_id="O2" value="66" lower_limit="1" upper_limit="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI</title>
        <time_frame>30 minutes to 1 hour after PCI</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Colchicine</title>
            <description>1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later&#xD;
Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo 1-2 hours prior PCI, followed by placebo 1 hour later&#xD;
Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI</title>
          <units>% change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-2" upper_limit="9"/>
                    <measurement group_id="O2" value="0" lower_limit="-5" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI</title>
        <time_frame>baseline to 22-24 hr after PCI</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Colchicine</title>
            <description>1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later&#xD;
Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo 1-2 hours prior PCI, followed by placebo 1 hour later&#xD;
Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI</title>
          <units>% change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O2" value="0" lower_limit="-9" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days, 6 months, and yearly for 5 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Colchicine</title>
          <description>1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later&#xD;
Colchicine: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo 1-2 hours prior PCI, followed by placebo 1 hour later&#xD;
Placebo: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hemodynamic instabiity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated creatinine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Ischemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </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="141"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="139"/>
              </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. Binita Shah</name_or_title>
      <organization>NYU Langone Health</organization>
      <phone>212-263-6631</phone>
      <email>Binita.Shah@nyulangone.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/NCT01709981
org study id: 11-02573
nct id: NCT01709981
lead sponsor: 
collaborator: 
Peri-procedural inflammation is associated with increased rates of post-procedural myocardial
      infarction (MI), which occur in up to 35% of PCI patients and are themselves associated with
      increased risk of later MI and death. Statins suppress both inflammatory markers and MI rates
      during and after PCI, but ≥ 40% of PCI patients go statin-untreated, due in part to side
      effects such as myalgia. Moreover, because their mechanism of action relies on
      post-translational effects, statins must be given ≥ 12 to 24 hours prior to PCI, a time frame
      that is not always feasible. The investigators propose a novel alternative approach to reduce
      inflammation during PCI employing colchicine, an anti-inflammatory medication used frequently
      in gout and pericarditis. Colchicine may be particularly applicable to the PCI setting due to
      its rapid onset of action and excellent side-effect profile at low doses, as well as its
      known mechanisms of action. However, data on colchicine use in patients with coronary disease
      is extremely limited, and no studies to date have evaluated the use of colchicine in patients
      undergoing PCI. The investigators aim to characterize a potential mechanism of benefit in
      patients undergoing PCI by evaluating the effects of colchicine on soluble and leukocyte
      surface markers after PCI. The investigators also aim to determine the effects of colchicine
      on peri-procedural myonecrosis and MI. Accordingly, the investigators propose a prospective
      randomized study to characterize the effect of colchicine on inflammation and peri-procedural
      myocnecrosis. Patients referred for possible PCI will be randomized in a double-blinded
      fashion to placebo or colchicine (1.2mg 1 to 2 hours before PCI, followed by 0.6mg 1 hour
      later). The primary endpoint will be post-procedural interleukin-6 level. Secondary endpoints
      will include other relevant soluble and leukocyte-associated inflammatory markers. Sample
      size needed is 200 patients undergoing PCI. To adjust for a floor effect, 280 patients
      undergoing PCI will be needed. 400 patients will likely be needed to be enrolled to reach 280
      PCIs (the remaining will have undergone a diagnostic only procedure). Of note, this is a
      substudy of the COLCHICINE-PCI trial (NCT 02594111)
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent Change in Post-procedural IL-6 Concentration From Baseline to 30 Min -1 hr After PCI
time frame: 30 minutes to 1 hour after PCI
measure: Percent Change in Post-procedural IL-6 Concentration From Baseline to 22-24 hr After PCI
time frame: baseline to 22-24 hr after PCI
measure: Percent Change in Post-procedural hsCRP Concentration From Baseline to 22-24 hr After PCI
time frame: baseline to 22-24 hr after PCI
measure: Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI
time frame: 30 minutes to 1 hour after PCI
measure: Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI
time frame: baseline to 22-24 hr after PCI
arm group label: Colchicine
arm group type: Experimental
description: 1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo 1-2 hours prior PCI, followed by placebo 1 hour later
intervention type: Drug
intervention name: Colchicine
description: Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later
arm group label: Colchicine
other name: Colcrys
intervention type: Drug
intervention name: Placebo
description: Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Binita Shah, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Colchicine
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 