<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/NCT03228017</url>
  </required_header>
  <id_info>
    <org_study_id>17-00692</org_study_id>
    <nct_id>NCT03228017</nct_id>
  </id_info>
  <brief_title>Subclinical Cardiovascular Disease in Psoriatic Disease</brief_title>
  <official_title>Subclinical Cardiovascular Disease in Psoriatic Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will look at how chronic inflammation seen in psoriatic disease translates into&#xD;
      the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk.&#xD;
      The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic&#xD;
      disease and measures of vascular function. 2) Evaluate the association between moderate to&#xD;
      severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional&#xD;
      medications used in cardiovascular disease (CVD) prevention such as aspirin and statins&#xD;
      affect vascular function and thrombotic risk in those with moderate to severe psoriatic&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease (CVD) remains the leading cause of death in the US. Five modifiable&#xD;
      risk factors: smoking, hyperlipidemia, diabetes, hypertension and obesity, account for 50% of&#xD;
      CVD mortality between the ages of 45 - 79.1 These traditional cardiac risk factors dictate&#xD;
      who to treat with primary prevention measures but do not take into account patient-specific&#xD;
      disease states such as psoriatic disease including psoriasis and psoriatic arthritis, which&#xD;
      predispose to chronic inflammation. Patients with psoriatic disease have an increased risk of&#xD;
      atherosclerotic heart disease and myocardial infarctions compared to matched controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript</measure>
    <time_frame>Baseline, 5 Months</time_frame>
    <description>Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fold Change Change in Composite Endothelial Inflammation</measure>
    <time_frame>Baseline (pre-Aspirin), 2 weeks (post-Aspirin)</time_frame>
    <description>Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fold Change in Composite Endothelial Inflammation</measure>
    <time_frame>Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin)</time_frame>
    <description>Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Levels of Circulating Thromboxane B2</measure>
    <time_frame>Baseline (pre-Aspirin), 2 weeks (post-Aspirin)</time_frame>
    <description>Platelet activation is measured by levels of circulating thromboxane b2, which will be measured after 2- weeks of aspirin 81mg therapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Atherosclerotic Cardiovascular Disease</condition>
  <condition>Thrombotic Vascular Disease</condition>
  <arm_group>
    <arm_group_label>Psoriatic Disease Patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Moderate to severe psoriatic disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin and/or Atorvastatin</intervention_name>
    <description>This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.</description>
    <arm_group_label>Psoriatic Disease Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of moderate to severe psoriatic disease&#xD;
&#xD;
          -  Group 2: Healthy subjects without known psoriatic disease or cardiovascular disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to speak Spanish or English&#xD;
&#xD;
          -  Active smoking (within the past year)&#xD;
&#xD;
          -  Autoimmune, rheumatologic or inflammatory disease which are not psoriasis or psoriatic&#xD;
             arthritis&#xD;
&#xD;
          -  Known active cancer receiving treatment&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Anemia (hemoglobin &lt; 9 mg/dl) or thrombocytopenia (Platelet count &lt;75), or&#xD;
             thrombocytosis (Platelet count &gt;600)&#xD;
&#xD;
          -  A history of severe bleeding or bleeding disorders&#xD;
&#xD;
          -  Current medication use which interact with either aspirin or atorvastatin&#xD;
&#xD;
          -  Chronic kidney disease (CrCl &lt; 30ml/min)&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  Currently taking aspirin or a statin.&#xD;
&#xD;
          -  NSAID use within the past 48 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Berger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</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>August 2021</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <results_first_submitted>March 5, 2021</results_first_submitted>
  <results_first_submitted_qc>August 31, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 28, 2021</results_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiovascular disease</keyword>
  <keyword>CVD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Atorvastatin</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>March 22, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03228017/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Psoriatic Disease Patients</title>
          <description>Moderate to severe psoriatic disease&#xD;
Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.</description>
        </group>
        <group group_id="P2">
          <title>Healthy Control</title>
          <description>Healthy Control</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="18"/>
              </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>Psoriatic Disease Patients</title>
          <description>Moderate to severe psoriatic disease&#xD;
Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.</description>
        </group>
        <group group_id="B2">
          <title>Healthy Control</title>
          <description>Healthy Control</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="45"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="63"/>
          </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="45" spread="14.2"/>
                    <measurement group_id="B2" value="40.5" spread="12.7"/>
                    <measurement group_id="B3" value="42.75" spread="13.5"/>
                  </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="23"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="32"/>
                  </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="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </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="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="49"/>
                  </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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </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="45"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript</title>
        <description>Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation</description>
        <time_frame>Baseline, 5 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Psoriatic Disease Patients</title>
            <description>Moderate to severe psoriatic disease&#xD;
Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Control</title>
            <description>Healthy Control</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript</title>
          <description>Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation</description>
          <units>Fold Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="8.6"/>
                    <measurement group_id="O2" value="2.8" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fold Change Change in Composite Endothelial Inflammation</title>
        <description>Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy</description>
        <time_frame>Baseline (pre-Aspirin), 2 weeks (post-Aspirin)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Psoriatic Disease Patients</title>
            <description>Moderate to severe psoriatic disease&#xD;
Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Control</title>
            <description>Healthy Control</description>
          </group>
        </group_list>
        <measure>
          <title>Fold Change Change in Composite Endothelial Inflammation</title>
          <description>Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy</description>
          <units>Fold Change</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.28" lower_limit="-0.4" upper_limit="-.15"/>
                    <measurement group_id="O2" value="-0.04" lower_limit="-0.17" upper_limit="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fold Change in Composite Endothelial Inflammation</title>
        <description>Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.</description>
        <time_frame>Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Psoriatic Disease Patients</title>
            <description>Moderate to severe psoriatic disease&#xD;
Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Control</title>
            <description>Healthy Control</description>
          </group>
        </group_list>
        <measure>
          <title>Fold Change in Composite Endothelial Inflammation</title>
          <description>Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.</description>
          <units>Fold Change</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-.21" upper_limit="-0.003"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-.04" upper_limit="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Levels of Circulating Thromboxane B2</title>
        <description>Platelet activation is measured by levels of circulating thromboxane b2, which will be measured after 2- weeks of aspirin 81mg therapy</description>
        <time_frame>Baseline (pre-Aspirin), 2 weeks (post-Aspirin)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Psoriatic Disease Patients</title>
            <description>Moderate to severe psoriatic disease&#xD;
Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Control</title>
            <description>Healthy Control</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Levels of Circulating Thromboxane B2</title>
          <description>Platelet activation is measured by levels of circulating thromboxane b2, which will be measured after 2- weeks of aspirin 81mg therapy</description>
          <units>ng/ml</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="0.8"/>
                    <measurement group_id="O2" value="4.05" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Psoriatic Disease Patients</title>
          <description>Moderate to severe psoriatic disease&#xD;
Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.</description>
        </group>
        <group group_id="E2">
          <title>Healthy Control</title>
          <description>Healthy Control</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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </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. Michael Garshick</name_or_title>
      <organization>NYU Langone</organization>
      <phone>212-263-0855</phone>
      <email>michael.garshick@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/NCT03228017
org study id: 17-00692
nct id: NCT03228017
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will look at how chronic inflammation seen in psoriatic disease translates into
      the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk.
      The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic
      disease and measures of vascular function. 2) Evaluate the association between moderate to
      severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional
      medications used in cardiovascular disease (CVD) prevention such as aspirin and statins
      affect vascular function and thrombotic risk in those with moderate to severe psoriatic
      disease.
Cardiovascular disease (CVD) remains the leading cause of death in the US. Five modifiable
      risk factors: smoking, hyperlipidemia, diabetes, hypertension and obesity, account for 50% of
      CVD mortality between the ages of 45 - 79.1 These traditional cardiac risk factors dictate
      who to treat with primary prevention measures but do not take into account patient-specific
      disease states such as psoriatic disease including psoriasis and psoriatic arthritis, which
      predispose to chronic inflammation. Patients with psoriatic disease have an increased risk of
      atherosclerotic heart disease and myocardial infarctions compared to matched controls.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript
time frame: Baseline, 5 Months
description: Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation
measure: Fold Change Change in Composite Endothelial Inflammation
time frame: Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
description: Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy
measure: Fold Change in Composite Endothelial Inflammation
time frame: Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin)
description: Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.
measure: Change in Levels of Circulating Thromboxane B2
time frame: Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
description: Platelet activation is measured by levels of circulating thromboxane b2, which will be measured after 2- weeks of aspirin 81mg therapy
arm group label: Psoriatic Disease Patients
arm group type: Other
description: Moderate to severe psoriatic disease
arm group label: Healthy Control
arm group type: No Intervention
intervention type: Drug
intervention name: Aspirin and/or Atorvastatin
description: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.
arm group label: Psoriatic Disease Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey Berger, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Myocardial Infarction
mesh term: Vascular Diseases
mesh term: Atherosclerosis
mesh term: Infarction
mesh term: Aspirin
mesh term: Atorvastatin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 