<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/NCT03008798</url>
  </required_header>
  <id_info>
    <org_study_id>2014A020221074</org_study_id>
    <nct_id>NCT03008798</nct_id>
  </id_info>
  <brief_title>Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117</brief_title>
  <acronym>PRISIT</acronym>
  <official_title>Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117--PRISIT Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Liaocheng People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liaoning Tumor Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhongshan People's Hospital, Guangdong, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangzhou University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal&#xD;
      medicine C117--PRISIT Trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intracranial artery stenosis (ICAS) is a common cause of ischemic stroke worldwide. At&#xD;
      present, percutaneous transluminal angioplasty and stenting serve as a possible treatment&#xD;
      option for ICAS patients, however, intracranial in-stent restenosis(ISR) limited its use in&#xD;
      clinical practice, which led to recurrent stroke even death, meanwhile, From the point of&#xD;
      chinese medicine, in-stent restenosis(ISR) regard as the unhealthy environmental influences&#xD;
      with shapes, therefore, we have design two control group on the basis of conventional&#xD;
      secondary prevention, one use herbal medicine for blood-acting and stasis-dissolving, and&#xD;
      another use the similar looking placebos, after 12 months of treatment, we will evaluate the&#xD;
      rate of all-cause stroke and all-cause mortality, moreover, we also record the Vascular&#xD;
      restenosis rate which may cause recurrent ischemic stroke, the aim of this study was to&#xD;
      evaluate the safety and efficacy of herbal medicine C-117.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the total number of all-cause mortality and all-cause stroke within 12 months</measure>
    <time_frame>After 12 months follow-up</time_frame>
    <description>After drug-use 12 months,observe all-cause mortality and all-cause stroke（hemorrhage or ischemic）.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of intracranial in-stent restenosis</measure>
    <time_frame>After 12 months follow-up period,record the rate of intracranial in-stent restenosis</time_frame>
    <description>After drug-use 12 months,observe the rate of intracranial in-stent restenosis where stent implantation.throgh the test of TCD, digital subtraction angiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The complications of intracranial in-stent restenosis</measure>
    <time_frame>After 12 months follow-up period,record the complications of intracranial in-stent restenosis</time_frame>
    <description>After drug-use 12 months,observe the complications of intracranial in-stent restenosis,including TIA and stroke,even death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIH Stroke Scale （NIHSS）</measure>
    <time_frame>After 12 months follow-up period</time_frame>
    <description>At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bathel index</measure>
    <time_frame>After 12 months follow-up period</time_frame>
    <description>At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS, Bathel index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified RANKIN score.</measure>
    <time_frame>After 12 months follow-up period</time_frame>
    <description>modified RANKIN score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Occlusion and Stenosis of Unspecified Cerebral Artery</condition>
  <arm_group>
    <arm_group_label>Herbal Medicine C-117</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The Placebo of Herbal Medicine C-117</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Herbal Medicine C-117</intervention_name>
    <description>C117 formula including 2 herbals and 2 insects</description>
    <arm_group_label>Herbal Medicine C-117</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>The Placebo of Herbal Medicine C-117</intervention_name>
    <arm_group_label>The Placebo of Herbal Medicine C-117</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Older than 18 years of age&#xD;
&#xD;
          2. 70-90% stenosis of intracranial responsible angiopathic area under the DSA angiography&#xD;
             (as judged through the WASID method);after operation vascular stenosis less than 50%.&#xD;
&#xD;
          3. The score of mRS≤3&#xD;
&#xD;
          4. To rule out intracranial hemorrhage by CT orMRI&#xD;
&#xD;
          5. Adhere to the medication&#xD;
&#xD;
        Exclusion Criteria：&#xD;
&#xD;
          1. Together with intracranial tumors or AVM&#xD;
&#xD;
          2. The lesion area where implant stent previons&#xD;
&#xD;
          3. Fetch intracranial artery thrombus by emergency surgical operation&#xD;
&#xD;
          4. Vascular serious circuity&#xD;
&#xD;
          5. Myocardial infarction need to antithrombotic&#xD;
&#xD;
          6. MoyaMoya disease or cerebral vasculitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yingguang Zhang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Province Hospital of Tradtional Chinese Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhangyong Xia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liaocheng People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jian Yang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liaoning Tumor Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wentong Ling, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhangshan People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianwen Guo, doctor</last_name>
    <phone>0086-13724899379</phone>
    <email>jianwen_guo@msn.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>jianwen guo, MD</last_name>
    <phone>(08620)81887233</phone>
    <phone_ext>30906</phone_ext>
    <email>306247680@qq.com</email>
  </overall_contact_backup>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>jianwen guo, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Intracranial Artery</keyword>
  <keyword>in-stent restenosis</keyword>
  <keyword>Herbal Medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Arteriosclerosis</mesh_term>
    <mesh_term>Intracranial Embolism</mesh_term>
    <mesh_term>Intracranial Thrombosis</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/NCT03008798
org study id: 2014A020221074
nct id: NCT03008798
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal
      medicine C117--PRISIT Trial
Intracranial artery stenosis (ICAS) is a common cause of ischemic stroke worldwide. At
      present, percutaneous transluminal angioplasty and stenting serve as a possible treatment
      option for ICAS patients, however, intracranial in-stent restenosis(ISR) limited its use in
      clinical practice, which led to recurrent stroke even death, meanwhile, From the point of
      chinese medicine, in-stent restenosis(ISR) regard as the unhealthy environmental influences
      with shapes, therefore, we have design two control group on the basis of conventional
      secondary prevention, one use herbal medicine for blood-acting and stasis-dissolving, and
      another use the similar looking placebos, after 12 months of treatment, we will evaluate the
      rate of all-cause stroke and all-cause mortality, moreover, we also record the Vascular
      restenosis rate which may cause recurrent ischemic stroke, the aim of this study was to
      evaluate the safety and efficacy of herbal medicine C-117.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: the total number of all-cause mortality and all-cause stroke within 12 months
time frame: After 12 months follow-up
description: After drug-use 12 months,observe all-cause mortality and all-cause stroke（hemorrhage or ischemic）.
measure: The rate of intracranial in-stent restenosis
time frame: After 12 months follow-up period,record the rate of intracranial in-stent restenosis
description: After drug-use 12 months,observe the rate of intracranial in-stent restenosis where stent implantation.throgh the test of TCD, digital subtraction angiography.
measure: The complications of intracranial in-stent restenosis
time frame: After 12 months follow-up period,record the complications of intracranial in-stent restenosis
description: After drug-use 12 months,observe the complications of intracranial in-stent restenosis,including TIA and stroke,even death.
measure: NIH Stroke Scale （NIHSS）
time frame: After 12 months follow-up period
description: At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS
measure: Bathel index
time frame: After 12 months follow-up period
description: At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS, Bathel index
measure: modified RANKIN score.
time frame: After 12 months follow-up period
description: modified RANKIN score.
arm group label: Herbal Medicine C-117
arm group type: Experimental
description: Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
arm group label: The Placebo of Herbal Medicine C-117
arm group type: Placebo Comparator
description: The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
intervention type: Drug
intervention name: Herbal Medicine C-117
description: C117 formula including 2 herbals and 2 insects
arm group label: Herbal Medicine C-117
intervention type: Drug
intervention name: The Placebo of Herbal Medicine C-117
arm group label: The Placebo of Herbal Medicine C-117
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yingguang Zhang, MD
role: Principal Investigator
affiliation: Guangdong Province Hospital of Tradtional Chinese Medicine
last name: Zhangyong Xia, MD
role: Principal Investigator
affiliation: Liaocheng People's Hospital
last name: Jian Yang, MD
role: Principal Investigator
affiliation: Liaoning Tumor Hospital & Institute
last name: Wentong Ling, MD
role: Principal Investigator
affiliation: Zhangshan People's Hospital
last name: Jianwen Guo, doctor
phone: 0086-13724899379
email: jianwen_guo@msn.com
last name: jianwen guo, MD
phone: (08620)81887233
phone ext: 30906
email: 306247680@qq.com
responsible party type: Principal Investigator
investigator affiliation: Guangzhou University of Traditional Chinese Medicine
investigator full name: jianwen guo, MD
investigator title: Professor
mesh term: Intracranial Arteriosclerosis
mesh term: Intracranial Embolism
mesh term: Intracranial Thrombosis