<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/NCT01681199</url>
  </required_header>
  <id_info>
    <org_study_id>AZYY-XNK-2012001</org_study_id>
    <nct_id>NCT01681199</nct_id>
  </id_info>
  <brief_title>Fluvastatin AmelIorates aTHerosclerosis Study</brief_title>
  <acronym>FAITH</acronym>
  <official_title>The Efficacy of Lescol XL(Fluvastatin Extended Release 80 mg) on Atherosclerosis Progression in Patients With Newly Diagnosed Coronary Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Anzhen Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to assess the effect of statin on atherosclesrosis progression as well&#xD;
      as to explore its potential mechanism besides lipid modifying , such as effect on&#xD;
      inflammation and vascular calcification.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Carotid IMT has been used in various studies (e.g. ASAP, ARBITER, METEOR) and is well&#xD;
      accepted as a valid surrogate marker for atherosclerosis. The thickness of CIMT is&#xD;
      significantly associated with the presence and the extent of coronary disease. Slower&#xD;
      progression of atherosclerosis as measured by carotid ultrasound is also associated with a&#xD;
      lower risk of nonfatal MI. In a meta analysis, for every 0.0 1-mm-per-year decrease in&#xD;
      carotid IMT, there was a significant 18% reduction in the risk of nonfatal MI. Measurement of&#xD;
      carotid IMT carries the advantage of being non-invasive and easy to use with a good degree of&#xD;
      reproducibility.&#xD;
&#xD;
      Statins have been shown to slow the progression of atherosclerosis or even to induce&#xD;
      regression of atherosclerosis. Change of carotid IMT by statins have been found to correlate&#xD;
      with the extent of LDL-C reduction and HDL-C increase however non-lipid effects (e.g. effects&#xD;
      on inflammation, calcification ) may also play a role in the beneficial effects of statins on&#xD;
      atherosclerosis.Osteopontin (OPN), an acidic phosphoprotein, and osteoprotegerin (OPG), a&#xD;
      member of the tumor necrosis factor-a receptor superfamily, have been recently demonstrated&#xD;
      to modulate vascular calcification. Recent studies have shown an association of serum OPN and&#xD;
      OPG levels with cardiovascular diseases and vulnerable carotid plaque .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">August 2014</completion_date>
  <primary_completion_date type="Anticipated">April 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>carotid IMT</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I</measure>
    <time_frame>week 12 and 24</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>hs-CRP, Lp-PLA2, OPN and OPG.</measure>
    <time_frame>week 12,24 and 52</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Coronary Heart Disease</condition>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>Fluvastatin extended release tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fluvastatin extended release tablet 80mg/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluvastatin extended release tablet</intervention_name>
    <arm_group_label>Fluvastatin extended release tablet</arm_group_label>
    <other_name>Lescol XL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Newly diagnosed coronary heart disease&#xD;
&#xD;
          2. One or more maximum IMT measurements of ≥1.1mm.&#xD;
&#xD;
          3. Age 45 to 70 years old&#xD;
&#xD;
          4. LDL-C≥130mg/dL&#xD;
&#xD;
          5. Not receiving regular lipid lowering treatment&#xD;
&#xD;
          6. Written Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Myocardial infarction as the first symptoms of coronary heart disease&#xD;
&#xD;
          2. Patients with known hypersensitivity to fluvastatin or any of the excipients&#xD;
&#xD;
          3. Pregnancy or lactation, or women of childbearing potential not using effective&#xD;
             contraception&#xD;
&#xD;
          4. Known muscle disease or history of muscle disease (e.g. myopathy, myositis,&#xD;
             rhabdomyolysis) and/or serum CK levels greater than 2 x upper limit of normal (ULN)&#xD;
&#xD;
          5. renal dysfunction&#xD;
&#xD;
          6. Active liver disease and/or serum transaminase levels (ALT, AST) greater than 2x ULN&#xD;
&#xD;
          7. Any conditions the investigator consider not suitable for long-term follow up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cardiology department ,Beijing Anzhen hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xin Du, PhD</last_name>
      <phone>86 15010519643</phone>
      <email>duxinheart@sina.com</email>
    </contact>
    <investigator>
      <last_name>Xin Du, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 5, 2012</last_update_submitted>
  <last_update_submitted_qc>September 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Anzhen Hospital</investigator_affiliation>
    <investigator_full_name>Chang sheng Ma</investigator_full_name>
    <investigator_title>director of cardiology department</investigator_title>
  </responsible_party>
  <keyword>statin</keyword>
  <keyword>atherosclerosis</keyword>
  <keyword>Coronary heart disease</keyword>
  <keyword>OPN</keyword>
  <keyword>OPG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_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/NCT01681199
org study id: AZYY-XNK-2012001
nct id: NCT01681199
lead sponsor: 
collaborator: 
has dmc: No
The study is designed to assess the effect of statin on atherosclesrosis progression as well
      as to explore its potential mechanism besides lipid modifying , such as effect on
      inflammation and vascular calcification.
Carotid IMT has been used in various studies (e.g. ASAP, ARBITER, METEOR) and is well
      accepted as a valid surrogate marker for atherosclerosis. The thickness of CIMT is
      significantly associated with the presence and the extent of coronary disease. Slower
      progression of atherosclerosis as measured by carotid ultrasound is also associated with a
      lower risk of nonfatal MI. In a meta analysis, for every 0.0 1-mm-per-year decrease in
      carotid IMT, there was a significant 18% reduction in the risk of nonfatal MI. Measurement of
      carotid IMT carries the advantage of being non-invasive and easy to use with a good degree of
      reproducibility.

      Statins have been shown to slow the progression of atherosclerosis or even to induce
      regression of atherosclerosis. Change of carotid IMT by statins have been found to correlate
      with the extent of LDL-C reduction and HDL-C increase however non-lipid effects (e.g. effects
      on inflammation, calcification ) may also play a role in the beneficial effects of statins on
      atherosclerosis.Osteopontin (OPN), an acidic phosphoprotein, and osteoprotegerin (OPG), a
      member of the tumor necrosis factor-a receptor superfamily, have been recently demonstrated
      to modulate vascular calcification. Recent studies have shown an association of serum OPN and
      OPG levels with cardiovascular diseases and vulnerable carotid plaque .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: carotid IMT
time frame: 1 year
measure: lipid variables:TC, TG, LDL-C, HDL-C, apo B, apo A-I
time frame: week 12 and 24
measure: hs-CRP, Lp-PLA2, OPN and OPG.
time frame: week 12,24 and 52
arm group label: Fluvastatin extended release tablet
arm group type: Experimental
description: Fluvastatin extended release tablet 80mg/day
intervention type: Drug
intervention name: Fluvastatin extended release tablet
arm group label: Fluvastatin extended release tablet
other name: Lescol XL
criteria: 
gender: All
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Anzhen Hospital
investigator full name: Chang sheng Ma
investigator title: director of cardiology department
mesh term: Heart Diseases
mesh term: Atherosclerosis
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia