<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/NCT03248401</url>
  </required_header>
  <id_info>
    <org_study_id>Cilostazol_Carotid a. plaque</org_study_id>
    <nct_id>NCT03248401</nct_id>
  </id_info>
  <brief_title>Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes</brief_title>
  <official_title>Effect of Cilostazol, a Phosphodiesterase 3 Inhibitor, on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in&#xD;
      patients with type 2 diabetes mellitus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2016</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 21, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of carotid artery atherosclerosis</measure>
    <time_frame>6 months</time_frame>
    <description>Plaque composition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of carotid artery atherosclerosis 1</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in carotid intima-media thickness after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of carotid artery atherosclerosis 2</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in carotid artery stenosis after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of carotid artery atherosclerosis 3</measure>
    <time_frame>6 months</time_frame>
    <description>Plaque volume in carotid artery</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Glucose metabolism 1</measure>
    <time_frame>6 months</time_frame>
    <description>HOMA-Insulin Resistance</description>
  </other_outcome>
  <other_outcome>
    <measure>Diabetic complication</measure>
    <time_frame>6 months</time_frame>
    <description>Albuminuria</description>
  </other_outcome>
  <other_outcome>
    <measure>Glucose metabolism 2</measure>
    <time_frame>6 months</time_frame>
    <description>HbA1c</description>
  </other_outcome>
  <other_outcome>
    <measure>Body composition</measure>
    <time_frame>6 months</time_frame>
    <description>Body fat mass and percent</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Carotid Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>Cilostazol group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cilostazol 200 mg or maximal tolerate dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aspirin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aspirin 100 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cilostazol</intervention_name>
    <description>Cilostazol 200 mg/day</description>
    <arm_group_label>Cilostazol group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>Aspirin 100 mg/day</description>
    <arm_group_label>Aspirin group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 30 and 80 years&#xD;
&#xD;
          -  Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%)&#xD;
&#xD;
          -  Carotid plaque on 3D ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute bleeding or bleeding tendency&#xD;
&#xD;
          -  Diagnosed with heart failure&#xD;
&#xD;
          -  Suggestive of ischemia on ECG&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Recently diagnosed with peptic ulcer disease&#xD;
&#xD;
          -  Taking other antiplatelet agents&#xD;
&#xD;
          -  Hypersensitivity to salicylic acid&#xD;
&#xD;
          -  Aspirin induced asthma&#xD;
&#xD;
          -  Severe kidney, liver, heart disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Katakami N, Kim YS, Kawamori R, Yamasaki Y. The phosphodiesterase inhibitor cilostazol induces regression of carotid atherosclerosis in subjects with type 2 diabetes mellitus: principal results of the Diabetic Atherosclerosis Prevention by Cilostazol (DAPC) study: a randomized trial. Circulation. 2010 Jun 15;121(23):2584-91. doi: 10.1161/CIRCULATIONAHA.109.892414. Epub 2010 Jun 1.</citation>
    <PMID>20516379</PMID>
  </reference>
  <reference>
    <citation>Huh JH, Seok H, Lee BW, Kang ES, Lee HC, Cha BS. Effect of cilostazol on carotid intima-media thickness in type 2 diabetic patients without cardiovascular event. Endocrine. 2014 Sep;47(1):138-45. doi: 10.1007/s12020-013-0120-y. Epub 2014 Jan 1.</citation>
    <PMID>24381128</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Soo Lim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Artery Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Cilostazol</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/NCT03248401
org study id: Cilostazol_Carotid a. plaque
nct id: NCT03248401
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in
      patients with type 2 diabetes mellitus
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change of carotid artery atherosclerosis
time frame: 6 months
description: Plaque composition
measure: Change of carotid artery atherosclerosis 1
time frame: 6 months
description: Changes in carotid intima-media thickness after treatment
measure: Change of carotid artery atherosclerosis 2
time frame: 6 months
description: Changes in carotid artery stenosis after treatment
measure: Change of carotid artery atherosclerosis 3
time frame: 6 months
description: Plaque volume in carotid artery
measure: Glucose metabolism 1
time frame: 6 months
description: HOMA-Insulin Resistance
measure: Diabetic complication
time frame: 6 months
description: Albuminuria
measure: Glucose metabolism 2
time frame: 6 months
description: HbA1c
measure: Body composition
time frame: 6 months
description: Body fat mass and percent
arm group label: Cilostazol group
arm group type: Experimental
description: Cilostazol 200 mg or maximal tolerate dose
arm group label: Aspirin group
arm group type: Active Comparator
description: Aspirin 100 mg
intervention type: Drug
intervention name: Cilostazol
description: Cilostazol 200 mg/day
arm group label: Cilostazol group
intervention type: Drug
intervention name: Aspirin
description: Aspirin 100 mg/day
arm group label: Aspirin group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
citation: Katakami N, Kim YS, Kawamori R, Yamasaki Y. The phosphodiesterase inhibitor cilostazol induces regression of carotid atherosclerosis in subjects with type 2 diabetes mellitus: principal results of the Diabetic Atherosclerosis Prevention by Cilostazol (DAPC) study: a randomized trial. Circulation. 2010 Jun 15;121(23):2584-91. doi: 10.1161/CIRCULATIONAHA.109.892414. Epub 2010 Jun 1.
PMID: 20516379
citation: Huh JH, Seok H, Lee BW, Kang ES, Lee HC, Cha BS. Effect of cilostazol on carotid intima-media thickness in type 2 diabetic patients without cardiovascular event. Endocrine. 2014 Sep;47(1):138-45. doi: 10.1007/s12020-013-0120-y. Epub 2014 Jan 1.
PMID: 24381128
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Soo Lim
investigator title: Professor
mesh term: Carotid Artery Diseases
mesh term: Atherosclerosis
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Aspirin
mesh term: Cilostazol