<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/NCT02245087</url>
  </required_header>
  <id_info>
    <org_study_id>ECAD001</org_study_id>
    <nct_id>NCT02245087</nct_id>
  </id_info>
  <brief_title>Eliminate Coronary Artery Disease</brief_title>
  <acronym>ECAD</acronym>
  <official_title>Eliminate Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether pharmacologic lowering of low density&#xD;
      lipoprotein cholesterol (LDL), initiated in healthy young to middle aged adults can eliminate&#xD;
      or markedly reduce the composite endpoint of incident all cause mortality, myocardial&#xD;
      infarction, stroke or coronary revascularization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of Funding&#xD;
  </why_stopped>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">September 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to first occurrence of myocardial infarction, revascularization, stroke or death from any cause in the follow up period</measure>
    <time_frame>Up to 10 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atorvastatin(Lipitor) in addition to the usual guideline based care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guideline based care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Current guidelines for lipid-management in healthy middle aged men and women only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>20 mg of atorvastatin daily</description>
    <arm_group_label>Atorvastatin</arm_group_label>
    <other_name>Lipitor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men 35-50 years of age&#xD;
&#xD;
          -  Women 45 - 59 years of age (must be sterile or &gt;2 years postmenopausal)&#xD;
&#xD;
          -  LDL cholesterol greater than 1.8 mmol/L (70 mg/dL) based on testing performed within 1&#xD;
             year&#xD;
&#xD;
          -  One risk factor for Coronary Heart Disease other than lipid abnormality:&#xD;
&#xD;
          -  Obesity and hypertension [BP &gt;140 mmHg systolic and waist circumference &gt; 100 cm in&#xD;
             men and &gt;90 cm in women]&#xD;
&#xD;
          -  family history of premature myocardial infarction [&lt;60 years]&#xD;
&#xD;
          -  South Asian ethnic history&#xD;
&#xD;
          -  currently smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently taking cholesterol lowering medication&#xD;
&#xD;
          -  Qualify for cholesterol lowering medication based on current guidelines&#xD;
&#xD;
          -  Significant renal dysfunction (creatinine clearance &lt;30 ml/min)&#xD;
&#xD;
          -  Significant hepatic dysfunction (AST/ALT &gt;2.0 times upper limit of normal)&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Progressive or terminal illness, or other condition in which subject is unlikely to&#xD;
             survive the study period&#xD;
&#xD;
          -  Known allergy, hypersensitivity (anaphylaxis) ar adverse reaction to any statin&#xD;
&#xD;
          -  Participation in a clinical trial (except observational studies) within previous 30&#xD;
             days&#xD;
&#xD;
          -  Received any investigation product within 30 days prior to participation in this&#xD;
             clinical trial&#xD;
&#xD;
          -  Previously enrolled in this clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Michael Farkouh, MD, FRCPC, MSc, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peter Munk Cardiac Centre, University Health Network</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael J Domanski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Killian De Blacam Family Medical Practice</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3A 2A3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Gregory Garrioch Family Medical Practice</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3E 3C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Reena Dhatt</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3E6C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>May 27, 2022</last_update_submitted>
  <last_update_submitted_qc>May 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
    <investigator_full_name>Michael Farkouh</investigator_full_name>
    <investigator_title>Chair of the Peter Munk Centre of Excellence in Multinational Clinical Trials, Peter Munk Cardiac Centre, UHN</investigator_title>
  </responsible_party>
  <keyword>atorvastatin</keyword>
  <keyword>coronary artery disease</keyword>
  <keyword>myocardial infarction</keyword>
  <keyword>stroke</keyword>
  <keyword>revascularization</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>Atorvastatin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02245087
org study id: ECAD001
nct id: NCT02245087
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether pharmacologic lowering of low density
      lipoprotein cholesterol (LDL), initiated in healthy young to middle aged adults can eliminate
      or markedly reduce the composite endpoint of incident all cause mortality, myocardial
      infarction, stroke or coronary revascularization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Time to first occurrence of myocardial infarction, revascularization, stroke or death from any cause in the follow up period
time frame: Up to 10 years
arm group label: Atorvastatin
arm group type: Experimental
description: Atorvastatin(Lipitor) in addition to the usual guideline based care
arm group label: Guideline based care
arm group type: No Intervention
description: Current guidelines for lipid-management in healthy middle aged men and women only.
intervention type: Drug
intervention name: Atorvastatin
description: 20 mg of atorvastatin daily
arm group label: Atorvastatin
other name: Lipitor
criteria: 
gender: All
minimum age: 35 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr Michael Farkouh, MD, FRCPC, MSc, FACC
role: Principal Investigator
affiliation: Peter Munk Cardiac Centre, University Health Network
last name: Michael J Domanski, MD
role: Principal Investigator
affiliation: University of Maryland Medical Center
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University Health Network, Toronto
investigator full name: Michael Farkouh
investigator title: Chair of the Peter Munk Centre of Excellence in Multinational Clinical Trials, Peter Munk Cardiac Centre, UHN
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Atorvastatin