<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/NCT03277079</url>
  </required_header>
  <id_info>
    <org_study_id>123/D/2017</org_study_id>
    <nct_id>NCT03277079</nct_id>
  </id_info>
  <brief_title>Low Dose Statins, Ezetimibe and Nutraceuticals</brief_title>
  <acronym>TACO</acronym>
  <official_title>Low Dose Statins, Ezetimibe and Nutraceuticals in Coronary Artery Disease Patients Intolerant to High Intensity Statin Treatment (TArget ChOlesterol)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      It remains unknown if the association between moderate to low intensity statin therapy and&#xD;
      ezetimibe and nutraceuticals might have a therapeutic role in high-intensity statin&#xD;
      intolerant patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study will be to evaluate whether the association between statin and&#xD;
      exetimibe vs statin + ezetimibe + nutraceuticals can lead to higher percentage of LDL target&#xD;
      achievement&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Therapeutic target</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>LDL cholesterol &lt; 70 mg/dl</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>statin + ezetimibe</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low dose statin associated with ezetimibe</description>
  </arm_group>
  <arm_group>
    <arm_group_label>statin + ezetimibe + Nutraceuticals</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low dose statin associated with ezetimibe and Nutraceuticals</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>statin + ezetimibe</intervention_name>
    <description>Combination of two drugs</description>
    <arm_group_label>statin + ezetimibe</arm_group_label>
    <arm_group_label>statin + ezetimibe + Nutraceuticals</arm_group_label>
    <other_name>Anticholesterol drug</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>statin + ezetimibe + Nutraceuticals</intervention_name>
    <description>Combination of two grus plus nutraceuticals</description>
    <arm_group_label>statin + ezetimibe</arm_group_label>
    <arm_group_label>statin + ezetimibe + Nutraceuticals</arm_group_label>
    <other_name>Anticholesterol drug</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with angiographically assessed diagnosis of coronary artery disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#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>Carlo Gaudio, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Sapienza University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francesco Pelliccia, MD</last_name>
    <phone>39064997</phone>
    <phone_ext>123</phone_ext>
    <email>f.pelliccia@mclink.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Giuseppe Marazzi, MD</last_name>
    <phone>39064997</phone>
    <phone_ext>456</phone_ext>
    <email>marazzig@gmai.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sapienza University</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Francesco Pelliccia</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>coronary artery disease</keyword>
  <keyword>LDL cholesterol</keyword>
  <keyword>therapeutic target</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>Coronary Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ezetimibe</mesh_term>
    <mesh_term>Hydroxymethylglutaryl-CoA Reductase Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03277079
org study id: 123/D/2017
nct id: NCT03277079
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It remains unknown if the association between moderate to low intensity statin therapy and
      ezetimibe and nutraceuticals might have a therapeutic role in high-intensity statin
      intolerant patients
The aim of this study will be to evaluate whether the association between statin and
      exetimibe vs statin + ezetimibe + nutraceuticals can lead to higher percentage of LDL target
      achievement
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Therapeutic target
time frame: Up to 3 months
description: LDL cholesterol < 70 mg/dl
arm group label: statin + ezetimibe
arm group type: Active Comparator
description: Low dose statin associated with ezetimibe
arm group label: statin + ezetimibe + Nutraceuticals
arm group type: Active Comparator
description: Low dose statin associated with ezetimibe and Nutraceuticals
intervention type: Drug
intervention name: statin + ezetimibe
description: Combination of two drugs
arm group label: statin + ezetimibe
arm group label: statin + ezetimibe + Nutraceuticals
other name: Anticholesterol drug
intervention type: Drug
intervention name: statin + ezetimibe + Nutraceuticals
description: Combination of two grus plus nutraceuticals
arm group label: statin + ezetimibe
arm group label: statin + ezetimibe + Nutraceuticals
other name: Anticholesterol drug
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlo Gaudio, MD
role: Study Chair
affiliation: Sapienza University
last name: Francesco Pelliccia, MD
phone: 39064997
phone ext: 123
email: f.pelliccia@mclink.it
last name: Giuseppe Marazzi, MD
phone: 39064997
phone ext: 456
email: marazzig@gmai.com
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Francesco Pelliccia
investigator title: Assistant Professor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Ezetimibe
mesh term: Hydroxymethylglutaryl-CoA Reductase Inhibitors
sharing ipd: No