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<?xml version="1.0" encoding="UTF-8"?>

<clinical_study rank="112636">

  <!-- This xml conforms to an XML Schema at:

    https://clinicaltrials.gov/ct2/html/images/info/public.xsd

 and an XML DTD at:

    https://clinicaltrials.gov/ct2/html/images/info/public.dtd -->

  <required_header>

    <download_date>ClinicalTrials.gov processed this data on December 16, 2015</download_date>

    <link_text>Link to the current ClinicalTrials.gov record.</link_text>

    <url>https://clinicaltrials.gov/show/NCT01162902</url>

  </required_header>

  <id_info>

    <org_study_id>ABC Trial</org_study_id>

    <nct_id>NCT01162902</nct_id>

  </id_info>

  <brief_title>Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation</brief_title>

  <official_title>Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation</official_title>

  <sponsors>

    <lead_sponsor>

      <agency>Seoul National University Hospital</agency>

      <agency_class>Other</agency_class>

    </lead_sponsor>

  </sponsors>

  <source>Seoul National University Hospital</source>

  <oversight_info>

    <authority>South Korea: Korea Food and Drug Administration (KFDA)</authority>

    <has_dmc>Yes</has_dmc>

  </oversight_info>

  <brief_summary>

    <textblock>

      Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta

      blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery

      disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more

      important than relieving angina symptom. Dysfunction of microvessel is one of the most

      important factor in patients with coronary artery disease. Recently, we developed the new

      non-invasive method of evaluating the microvessel in fundus. With this methods, we will

      compare the effect of each drug (beta blocker, CCB, ARB).

    </textblock>

  </brief_summary>

  <overall_status>Not yet recruiting</overall_status>

  <start_date>September 2013</start_date>

  <completion_date type="Anticipated">December 2015</completion_date>

  <primary_completion_date type="Anticipated">January 2015</primary_completion_date>

  <phase>Phase 4</phase>

  <study_type>Interventional</study_type>

  <study_design>Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment</study_design>

  <primary_outcome>

    <measure>Wall to lumen ratio of fundus vessel</measure>

    <time_frame>baseline, 9 months</time_frame>

    <safety_issue>No</safety_issue>

    <description>Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up</description>

  </primary_outcome>

  <secondary_outcome>

    <measure>lipid parameter</measure>

    <time_frame>baseline, 9 months</time_frame>

    <safety_issue>No</safety_issue>

    <description>Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL</description>

  </secondary_outcome>

  <secondary_outcome>

    <measure>Serum markers of inflammation</measure>

    <time_frame>baseline, 9 months</time_frame>

    <safety_issue>No</safety_issue>

    <description>CRP</description>

  </secondary_outcome>

  <secondary_outcome>

    <measure>Change of nitrate need</measure>

    <time_frame>baseline, 1 months, and 3 months</time_frame>

    <safety_issue>No</safety_issue>

    <description>Measure of change of nitrate need</description>

  </secondary_outcome>

  <number_of_arms>3</number_of_arms>

  <enrollment type="Anticipated">150</enrollment>

  <condition>Stable Angina</condition>

  <arm_group>

    <arm_group_label>Diltiazem treated group</arm_group_label>

    <arm_group_type>Experimental</arm_group_type>

    <description>Diltiazem 180mg treated group</description>

  </arm_group>

  <arm_group>

    <arm_group_label>Bisoprolol treated group</arm_group_label>

    <arm_group_type>Active Comparator</arm_group_type>

    <description>Bisoprolol 5mg treated group</description>

  </arm_group>

  <arm_group>

    <arm_group_label>Candesartan treated group</arm_group_label>

    <arm_group_type>Active Comparator</arm_group_type>

    <description>Candesartan 32mg treated group</description>

  </arm_group>

  <intervention>

    <intervention_type>Drug</intervention_type>

    <intervention_name>Diltiazem treated group</intervention_name>

    <description>Diltiazem 180mg for 9 months</description>

    <arm_group_label>Diltiazem treated group</arm_group_label>

  </intervention>

  <intervention>

    <intervention_type>Drug</intervention_type>

    <intervention_name>Bisoprolol treated group</intervention_name>

    <description>Bisoprolol 5mg for 9 months</description>

    <arm_group_label>Bisoprolol treated group</arm_group_label>

  </intervention>

  <intervention>

    <intervention_type>Drug</intervention_type>

    <intervention_name>Candesartan treated group</intervention_name>

    <description>Candesartan 32mg for 9 months</description>

    <arm_group_label>Candesartan treated group</arm_group_label>

  </intervention>

  <eligibility>

    <criteria>

      <textblock>

        Inclusion Criteria:



          -  Stable angina patients whose coronary lesions is confirmed by angiography or receives

             PCI



          -  Unstable Angina/NSTEMI patients who completed PCI for main lesions



          -  Either systolic &gt; 130mmHg or diastolic &gt; 80mmHg, or patients with anti-hypertensive

             drugs



        Exclusion Criteria:



          -  STEMI patients within one month



          -  Variant Angina



          -  Liver function abnormality or renal failure



          -  History of Hypersensitivity to testing drugs



          -  Severe heart failure(NYHA class&gt;3) or uncorrectable hematologic disease



          -  Woman possible to be pregnant



          -  Uncontrolled diabetes



          -  Expected life span &lt; one year

      </textblock>

    </criteria>

    <gender>Both</gender>

    <minimum_age>30 Years</minimum_age>

    <maximum_age>80 Years</maximum_age>

    <healthy_volunteers>No</healthy_volunteers>

  </eligibility>

  <overall_contact>

    <last_name>Hae-Young Lee, MD, PhD</last_name>

    <phone>82-10-4528-6160</phone>

    <email>hylee612@snu.ac.kr</email>

  </overall_contact>

  <overall_contact_backup>

    <last_name>Hyo-Soo Kim, MD, PhD</last_name>

    <phone>82-2-2072-2226</phone>

    <email>hyosoo@snu.ac.kr</email>

  </overall_contact_backup>

  <location>

    <facility>

      <name>Seoul National University Hospital</name>

      <address>

        <city>Seoul</city>

        <country>Korea, Republic of</country>

      </address>

    </facility>

    <status>Not yet recruiting</status>

    <investigator>

      <last_name>Hyo-Soo Kim, MD, PhD</last_name>

      <role>Principal Investigator</role>

    </investigator>

    <investigator>

      <last_name>Hae-Young Lee, MD,PhD</last_name>

      <role>Sub-Investigator</role>

    </investigator>

  </location>

  <location_countries>

    <country>Korea, Republic of</country>

  </location_countries>

  <verification_date>December 2013</verification_date>

  <lastchanged_date>December 15, 2013</lastchanged_date>

  <firstreceived_date>April 30, 2010</firstreceived_date>

  <responsible_party>

    <name_title>Hyo-Soo, Kim</name_title>

    <organization>Seoul National University Hospital</organization>

  </responsible_party>

  <is_fda_regulated>No</is_fda_regulated>

  <has_expanded_access>No</has_expanded_access>

  <condition_browse>

    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm  -->

    <mesh_term>Angina, Stable</mesh_term>

  </condition_browse>

  <intervention_browse>

    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm  -->

    <mesh_term>Bisoprolol</mesh_term>

    <mesh_term>Candesartan</mesh_term>

    <mesh_term>Candesartan cilexetil</mesh_term>

    <mesh_term>Diltiazem</mesh_term>

  </intervention_browse>

  <!-- Results have not yet been posted for this study                                -->

</clinical_study>