<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/NCT01707615</url>
  </required_header>
  <id_info>
    <org_study_id>2010GGC10294</org_study_id>
    <nct_id>NCT01707615</nct_id>
  </id_info>
  <brief_title>Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use</brief_title>
  <acronym>GSPE</acronym>
  <official_title>Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jie Qiu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Natural Science Foundation of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical&#xD;
      use&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atherosclerotic plaques indicate the occurrence of ischemia events and how to deal with it is&#xD;
      a difficult task for clinical physicians. Grape seed proanthocyanidin extrat (GSPE) has been&#xD;
      reported to exert an antiatherogenic effect by inducing regression of atherosclerotic plaques&#xD;
      in animal experimental studies. In this study, the antiatherogenic effect of GSPE has been&#xD;
      investigated in clinical use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2006</start_date>
  <completion_date type="Actual">October 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</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>Carotid B-Mode Ultrasound</measure>
    <time_frame>Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months.</time_frame>
    <description>The common, internal, and external carotid arteries were carefully identified by combining B-mode ultrasonography and color-Doppler duplex examination in the anterior oblique, lateral, and posterior oblique planes. All data was collected in 12 segments: the near （intimal-luminal surface) and far (medial- adventitial) walls of the distal common (1 cm proximal to dilation of the carotid bulb), the bifurcation (1cm proximal to the flow divider), and the proximal internal (1 cm section of the internal carotid artery immediately distal to the flow divider) left and right carotid artery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical vascular events</measure>
    <time_frame>after 24 months follow-up</time_frame>
    <description>including hospital readmission for unstable angina, myocardial infarction, stroke, TIA, an arterial revascularization procedure (percutaneous coronary revascularization or coronary bypass surgery) and cardiac death.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">287</enrollment>
  <condition>Atherosclerosis of Arteries of the Extremities, Unspecified</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In the control group, all patients were enrolled in a lifestyle intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSPE group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSPE</intervention_name>
    <description>GSPE 240 mg/day (120mg bid)</description>
    <arm_group_label>GSPE group</arm_group_label>
    <other_name>Grape seed proanthocyanidin extrat</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>lifestyle intervention</intervention_name>
    <description>dietary modification making the total ingestion of calories into standard body weight 25 kCal in effect and an individualized home exercise program of a minimum 150 min/week of moderate-intensity physical activity</description>
    <arm_group_label>GSPE group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) carotid ultrasound examination: presence of carotid plaque or abnormal CIMT of&#xD;
             between 0.9 and 1.2mm; (2) lipid profile: LDL≦3.12mmol/L, TC≦5.2mmol/L; (3) no&#xD;
             lipid-lowering treatment within the past 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cardiomyopathy, acute coronary syndrome, hepatic dysfunction, end-stage renal&#xD;
             failure (serum creatinine ≥117mmol/L), prior carotid endarterectomy, and/or patients&#xD;
             who did not agree to participate in the present study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>43 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie Qiu, doctor</last_name>
    <role>Study Director</role>
    <affiliation>Qilu Hospital of Shandong University</affiliation>
  </overall_official>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 14, 2012</last_update_submitted>
  <last_update_submitted_qc>October 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Jie Qiu</investigator_full_name>
    <investigator_title>Qilu Hospital of Shandong University</investigator_title>
  </responsible_party>
  <keyword>proanthocyanidin,atherosclerosis, carotid plaque</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Plaque, Atherosclerotic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Proanthocyanidin</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/NCT01707615
org study id: 2010GGC10294
nct id: NCT01707615
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical
      use
Atherosclerotic plaques indicate the occurrence of ischemia events and how to deal with it is
      a difficult task for clinical physicians. Grape seed proanthocyanidin extrat (GSPE) has been
      reported to exert an antiatherogenic effect by inducing regression of atherosclerotic plaques
      in animal experimental studies. In this study, the antiatherogenic effect of GSPE has been
      investigated in clinical use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Carotid B-Mode Ultrasound
time frame: Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months.
description: The common, internal, and external carotid arteries were carefully identified by combining B-mode ultrasonography and color-Doppler duplex examination in the anterior oblique, lateral, and posterior oblique planes. All data was collected in 12 segments: the near （intimal-luminal surface) and far (medial- adventitial) walls of the distal common (1 cm proximal to dilation of the carotid bulb), the bifurcation (1cm proximal to the flow divider), and the proximal internal (1 cm section of the internal carotid artery immediately distal to the flow divider) left and right carotid artery.
measure: clinical vascular events
time frame: after 24 months follow-up
description: including hospital readmission for unstable angina, myocardial infarction, stroke, TIA, an arterial revascularization procedure (percutaneous coronary revascularization or coronary bypass surgery) and cardiac death.
arm group label: control group
arm group type: Other
description: In the control group, all patients were enrolled in a lifestyle intervention
arm group label: GSPE group
arm group type: Active Comparator
description: GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
intervention type: Drug
intervention name: GSPE
description: GSPE 240 mg/day (120mg bid)
arm group label: GSPE group
other name: Grape seed proanthocyanidin extrat
intervention type: Other
intervention name: lifestyle intervention
description: dietary modification making the total ingestion of calories into standard body weight 25 kCal in effect and an individualized home exercise program of a minimum 150 min/week of moderate-intensity physical activity
arm group label: GSPE group
arm group label: control group
criteria: 
gender: All
minimum age: 43 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jie Qiu, doctor
role: Study Director
affiliation: Qilu Hospital of Shandong University
responsible party type: Sponsor-Investigator
investigator affiliation: Shandong University
investigator full name: Jie Qiu
investigator title: Qilu Hospital of Shandong University
mesh term: Atherosclerosis
mesh term: Plaque, Atherosclerotic
mesh term: Proanthocyanidin