xml: <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/NCT05984953</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY-22-01743</org_study_id>
      <nct_id>NCT05984953</nct_id>
    </id_info>
    <brief_title>Rosuvastatin and Evolocumab for Coronary Artery Disease</brief_title>
    <acronym>Yellow V</acronym>
    <official_title>Effect of Statins and Evolocumab on Peripheral Blood Mononuclear Cell Gene Expression in Patients With Coronary Artery Disease: Yellow V</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Icahn School of Medicine at Mount Sinai</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</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 aim of the retrospective study is to characterize the molecular mechanisms responsible&#xD;
        for the effect of statins and evolocumab in patients with stable coronary artery disease. The&#xD;
        research team will retrieve and review intravascular imaging and gene expression data&#xD;
        previously collected in the catheterization laboratory during the following time-period:&#xD;
        8/1/2013-4/14/2015 and 5/4/2021 - 10/28/2022.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The researchers will use the previously collected transcriptomic and intravascular imaging&#xD;
        data collected from subjects between 8/1/2013-4/14/2015 (statin group) and subjects who&#xD;
        participated in YELLOW III study (evolocumab group). The analyses will allow us detect common&#xD;
        and unique pathways for each drug. The researchers will use intravascular imaging findings&#xD;
        (optical coherence tomography, OCT) to characterize patient's individual response to&#xD;
        treatment as beneficial, if OCT fibrous cap thickness (FCT) increased at follow-up and&#xD;
        develop machine-learning models to predict the individual response using baseline gene&#xD;
        expression.&#xD;
  &#xD;
        The researchers hypothesize that the analyses will uncover unique gene panels predicting&#xD;
        beneficial response to statin and evolocumab allowing to select the best treatment approach&#xD;
        for an individual patient. The total number of subjects will be 195. Transcriptomic profile&#xD;
        of PBMC at baseline and follow-up will be compared between the groups to establish the common&#xD;
        and distinctive molecular mechanisms of the effect of statins and evolocumab.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2013</start_date>
    <completion_date type="Actual">October 28, 2022</completion_date>
    <primary_completion_date type="Actual">October 28, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Expression levels of mRNA in blood cells</measure>
      <time_frame>18 month</time_frame>
      <description>Expression levels of mRNA in blood cells of the patients to be measured to identify the genes which are associated with a beneficial response to treatment using transcriptomic analysis of PBMC to find the key genes (biomarkers) responsible for effective therapy.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">195</enrollment>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>Statin</arm_group_label>
      <description>85 patients treated with statin</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Evolocumab</arm_group_label>
      <description>110 patients treated with evolocumab in addition to statin or evolocumab alone</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>statin</intervention_name>
      <description>40 mg of rosuvastatin daily for 8-12 weeks</description>
      <arm_group_label>Evolocumab</arm_group_label>
      <arm_group_label>Statin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>evolocumab</intervention_name>
      <description>140 mg evolocumab every 2 weeks (26 weeks)</description>
      <arm_group_label>Evolocumab</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects with coronary artery disease who underwent cardiac catheterization with or without&#xD;
          PCI&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects with coronary artery disease who underwent cardiac catheterization with or&#xD;
               without PCI&#xD;
  &#xD;
            -  Patients from 8/1/2013-4/14/2015 and YELLOW III with both visits available, baseline&#xD;
               and follow-up&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients from 8/1/2013-4/14/2015 and YELLOW III lost to follow-up&#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>Annapoorna Kini, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>MOUNT SINAI HOSPITAL</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mount Sinai Hospital</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10029</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Annapoorna Kini</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <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>Coronary Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Evolocumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Beginning 9 months and ending 36 months following article publication.</ipd_time_frame>
      <ipd_access_criteria>Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.&#xD;
  To achieve aims in the approved proposal. Proposals should be directed to annapoorna.kini@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd).</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984953
  org study id: STUDY-22-01743
  nct id: NCT05984953
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The aim of the retrospective study is to characterize the molecular mechanisms responsible
        for the effect of statins and evolocumab in patients with stable coronary artery disease. The
        research team will retrieve and review intravascular imaging and gene expression data
        previously collected in the catheterization laboratory during the following time-period:
        8/1/2013-4/14/2015 and 5/4/2021 - 10/28/2022.
  The researchers will use the previously collected transcriptomic and intravascular imaging
        data collected from subjects between 8/1/2013-4/14/2015 (statin group) and subjects who
        participated in YELLOW III study (evolocumab group). The analyses will allow us detect common
        and unique pathways for each drug. The researchers will use intravascular imaging findings
        (optical coherence tomography, OCT) to characterize patient's individual response to
        treatment as beneficial, if OCT fibrous cap thickness (FCT) increased at follow-up and
        develop machine-learning models to predict the individual response using baseline gene
        expression.
  
        The researchers hypothesize that the analyses will uncover unique gene panels predicting
        beneficial response to statin and evolocumab allowing to select the best treatment approach
        for an individual patient. The total number of subjects will be 195. Transcriptomic profile
        of PBMC at baseline and follow-up will be compared between the groups to establish the common
        and distinctive molecular mechanisms of the effect of statins and evolocumab.
  observational model: Cohort
  time perspective: Retrospective
  measure: Expression levels of mRNA in blood cells
  time frame: 18 month
  description: Expression levels of mRNA in blood cells of the patients to be measured to identify the genes which are associated with a beneficial response to treatment using transcriptomic analysis of PBMC to find the key genes (biomarkers) responsible for effective therapy.
  arm group label: Statin
  description: 85 patients treated with statin
  arm group label: Evolocumab
  description: 110 patients treated with evolocumab in addition to statin or evolocumab alone
  intervention type: Drug
  intervention name: statin
  description: 40 mg of rosuvastatin daily for 8-12 weeks
  arm group label: Evolocumab
  arm group label: Statin
  intervention type: Drug
  intervention name: evolocumab
  description: 140 mg evolocumab every 2 weeks (26 weeks)
  arm group label: Evolocumab
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Annapoorna Kini, MD
  role: Principal Investigator
  affiliation: MOUNT SINAI HOSPITAL
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Annapoorna Kini
  investigator title: Professor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  mesh term: Evolocumab
  sharing ipd: Yes
  ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Beginning 9 months and ending 36 months following article publication.
  ipd access criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
  To achieve aims in the approved proposal. Proposals should be directed to annapoorna.kini@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd).