<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/NCT02232360</url>
  </required_header>
  <id_info>
    <org_study_id>STAFENO</org_study_id>
    <nct_id>NCT02232360</nct_id>
  </id_info>
  <brief_title>Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone</brief_title>
  <official_title>The Comparative Analysis of the Effects on Plaque Volume and Tissue Characteristics Between Combined Therapy With STAatin Plus FENOfibrate and Statin Alone in Mild to Moderate, Non- Intervened Coronary Artery Stenosis (STAFENO Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gachon University Gil Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daewoong Pharmaceutical Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Gachon University Gil Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine effects of combination therapy with rosuvastatin&#xD;
      and fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary&#xD;
      lesions with intermediate stenosis in patient with coronary artery disease, compared with&#xD;
      rosuvastatin alone therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. In the&#xD;
      past few decades, optimal pharmacological therapies with statins targeting LDL-cholesterol&#xD;
      substantially reduce the risks of cardiovascular disease. However, the residual&#xD;
      cardiovascular risk is still high, requiring need for additional preventive therapies to&#xD;
      achieve even greater risk reduction.&#xD;
&#xD;
      Recent meta-analysis demonstrated fibrates can reduce the risk of coronary events and might&#xD;
      have a role in patients with high cardiovascular risks or combined dyslipidemia. Likewise,&#xD;
      fenofibrate had a possible benefit for patients with high triglyceride level and low&#xD;
      HDL-cholesterol level in the post-hoc analysis of ACCORD or FIELD trials.&#xD;
&#xD;
      Thus, investigators tried to determine effects of combination therapy with rosuvastatin and&#xD;
      fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary&#xD;
      lesions with intermediate stenosis in patient with coronary artery disease, compared with&#xD;
      rosuvastatin alone therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions</measure>
    <time_frame>After 12±2 months treatment</time_frame>
    <description>Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions by VH-IVUS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions</measure>
    <time_frame>After 12±2 months treatment</time_frame>
    <description>Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions by VH-IVUS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of thin-cap fibroatheroma</measure>
    <time_frame>After 12±2 months treatment</time_frame>
    <description>change of plaque phenotype by VH-IVUS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume</measure>
    <time_frame>After 12±2 months treatment</time_frame>
    <description>Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume by VH-IVUS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remodeling index</measure>
    <time_frame>After 12±2 months treatment</time_frame>
    <description>Remodeling index by VH-IVUS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events (MACE)</measure>
    <time_frame>After 12 months treatment</time_frame>
    <description>The composites of all-cause death, non-fatal myocardial infarction, stroke, culprit lesion revascularization, or non-culprit lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse drug events</measure>
    <time_frame>After 12±2 months treatment</time_frame>
    <description>Adverse drug events related by study drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatine phosphokinase</measure>
    <time_frame>After 12±2 months treatment</time_frame>
    <description>measurement of muscular side effects related by study drugs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">106</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Rosuvastatin and fenofibrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rosuvastatin alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rosuvastatin 10 mg per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin and fenofibrate</intervention_name>
    <description>Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day</description>
    <arm_group_label>Rosuvastatin and fenofibrate</arm_group_label>
    <other_name>Combination therapy with rosuvastatin and fenofibrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin alone</intervention_name>
    <description>Rosuvastatin 10mg per day</description>
    <arm_group_label>Rosuvastatin alone</arm_group_label>
    <other_name>Rosuvastatin alone therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with coronary artery disease who were 20 years of age or older and needed&#xD;
             coronary angiography&#xD;
&#xD;
          -  Intermediate coronary artery stenosis (diameter stenosis ≥30% to ≤60% by visual&#xD;
             estimation, diameter ≥2.0 mm to ≤4.0 mm, de novo lesion in native coronary artery) in&#xD;
             which virtual histology-intravascular ultrasound (VH-IVUS) could be feasible&#xD;
&#xD;
          -  Combined dyslipidemia&#xD;
&#xD;
               -  Stain-naive patients - LDL-cholesterol ≥70 mg/dL and non-HDL-cholesterol ≥130&#xD;
                  mg/dL&#xD;
&#xD;
               -  Patients taking statin within 2 weeks - LDL-cholesterol &lt; 100 mg/dL and&#xD;
                  non-HDL-cholesterol ≥100 mg/dL&#xD;
&#xD;
          -  Patients who gave written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetic patients&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Heart failure with symptoms of New York Heart Association class III/IV or left&#xD;
             ventricular ejection fraction &lt;35%&#xD;
&#xD;
          -  Renal dysfunction (creatinine level ≥1.7 mg/dL or dependence of dialysis&#xD;
&#xD;
          -  Hepatic dysfunction (transaminase level &gt; 3 times of normal within limit)&#xD;
&#xD;
          -  Pregnancy or breast-feeding women&#xD;
&#xD;
          -  Familial hypercholesterolemia&#xD;
&#xD;
          -  Hypertriglyceridemia (triglyceride level &gt;500 mg/dL)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seung Hwan Han, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gachon University Gil Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Seung Hwan Han, MD</last_name>
    <phone>82-32-460-3054</phone>
    <email>shhan@gilhospital.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pyung Chun Oh, MD</last_name>
    <phone>82-32-460-3054</phone>
    <email>likemed@gilhospital.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Konyang University Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jang Ho Bae, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jang Ho Bae, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Medical School and Hospital</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Young-Joon Hong, MD</last_name>
    </contact>
    <investigator>
      <last_name>Young-Joon Hong, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Inje University ilsanPaik Hospital</name>
      <address>
        <city>Ilsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sung Yoon Lee, MD</last_name>
    </contact>
    <investigator>
      <last_name>Sung Yoon Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>405-760</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seung Hwan Han, MD, PhD</last_name>
      <phone>82-32-460-3054</phone>
      <email>shhan@gilhospital.com</email>
    </contact>
    <investigator>
      <last_name>Seung Hwan Han, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chung-Ang University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sang-Wook Kim, MD</last_name>
    </contact>
    <investigator>
      <last_name>Sang-Wook Kim, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seoul National Univesity Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sang Hyun Kim, MD</last_name>
    </contact>
    <investigator>
      <last_name>Sang Hyun Kim, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>May 12, 2019</last_update_submitted>
  <last_update_submitted_qc>May 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gachon University Gil Medical Center</investigator_affiliation>
    <investigator_full_name>Seung Hwan Han</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Atherosclerotic plaque</keyword>
  <keyword>Virtual histology intravascular ultrasound</keyword>
  <keyword>Plaque composition</keyword>
  <keyword>Rosuvastatin</keyword>
  <keyword>Fenofibrate</keyword>
  <keyword>Coronary artery disease</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>Rosuvastatin Calcium</mesh_term>
    <mesh_term>Fenofibrate</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/NCT02232360
org study id: STAFENO
nct id: NCT02232360
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine effects of combination therapy with rosuvastatin
      and fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary
      lesions with intermediate stenosis in patient with coronary artery disease, compared with
      rosuvastatin alone therapy.
Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. In the
      past few decades, optimal pharmacological therapies with statins targeting LDL-cholesterol
      substantially reduce the risks of cardiovascular disease. However, the residual
      cardiovascular risk is still high, requiring need for additional preventive therapies to
      achieve even greater risk reduction.

      Recent meta-analysis demonstrated fibrates can reduce the risk of coronary events and might
      have a role in patients with high cardiovascular risks or combined dyslipidemia. Likewise,
      fenofibrate had a possible benefit for patients with high triglyceride level and low
      HDL-cholesterol level in the post-hoc analysis of ACCORD or FIELD trials.

      Thus, investigators tried to determine effects of combination therapy with rosuvastatin and
      fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary
      lesions with intermediate stenosis in patient with coronary artery disease, compared with
      rosuvastatin alone therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions
time frame: After 12±2 months treatment
description: Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions by VH-IVUS
measure: Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions
time frame: After 12±2 months treatment
description: Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions by VH-IVUS
measure: Presence of thin-cap fibroatheroma
time frame: After 12±2 months treatment
description: change of plaque phenotype by VH-IVUS
measure: Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume
time frame: After 12±2 months treatment
description: Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume by VH-IVUS
measure: Remodeling index
time frame: After 12±2 months treatment
description: Remodeling index by VH-IVUS
measure: Major adverse cardiovascular events (MACE)
time frame: After 12 months treatment
description: The composites of all-cause death, non-fatal myocardial infarction, stroke, culprit lesion revascularization, or non-culprit lesion revascularization
measure: Adverse drug events
time frame: After 12±2 months treatment
description: Adverse drug events related by study drugs
measure: Creatine phosphokinase
time frame: After 12±2 months treatment
description: measurement of muscular side effects related by study drugs
arm group label: Rosuvastatin and fenofibrate
arm group type: Experimental
description: Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day
arm group label: Rosuvastatin alone
arm group type: Active Comparator
description: Rosuvastatin 10 mg per day
intervention type: Drug
intervention name: Rosuvastatin and fenofibrate
description: Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day
arm group label: Rosuvastatin and fenofibrate
other name: Combination therapy with rosuvastatin and fenofibrate
intervention type: Drug
intervention name: Rosuvastatin alone
description: Rosuvastatin 10mg per day
arm group label: Rosuvastatin alone
other name: Rosuvastatin alone therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Seung Hwan Han, MD
role: Principal Investigator
affiliation: Gachon University Gil Medical Center
last name: Seung Hwan Han, MD
phone: 82-32-460-3054
email: shhan@gilhospital.com
last name: Pyung Chun Oh, MD
phone: 82-32-460-3054
email: likemed@gilhospital.com
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gachon University Gil Medical Center
investigator full name: Seung Hwan Han
investigator title: Professor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Rosuvastatin Calcium
mesh term: Fenofibrate