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Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117 (PRISIT)

Primary Purpose

Occlusion and Stenosis of Unspecified Cerebral Artery

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Herbal Medicine C-117
The Placebo of Herbal Medicine C-117
Sponsored by
Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Occlusion and Stenosis of Unspecified Cerebral Artery focused on measuring Intracranial Artery, in-stent restenosis, Herbal Medicine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Older than 18 years of age
  2. 70-90% stenosis of intracranial responsible angiopathic area under the DSA angiography (as judged through the WASID method);after operation vascular stenosis less than 50%.
  3. The score of mRS≤3
  4. To rule out intracranial hemorrhage by CT orMRI
  5. Adhere to the medication

Exclusion Criteria：

  1. Together with intracranial tumors or AVM
  2. The lesion area where implant stent previons
  3. Fetch intracranial artery thrombus by emergency surgical operation
  4. Vascular serious circuity
  5. Myocardial infarction need to antithrombotic
  6. MoyaMoya disease or cerebral vasculitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Herbal Medicine C-117

    The Placebo of Herbal Medicine C-117

    Arm Description

    Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year

    The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year

    Outcomes

    Primary Outcome Measures

    the total number of all-cause mortality and all-cause stroke within 12 months
    After drug-use 12 months,observe all-cause mortality and all-cause stroke（hemorrhage or ischemic）.

    Secondary Outcome Measures

    The rate of intracranial in-stent restenosis
    After drug-use 12 months,observe the rate of intracranial in-stent restenosis where stent implantation.throgh the test of TCD, digital subtraction angiography.
    The complications of intracranial in-stent restenosis
    After drug-use 12 months,observe the complications of intracranial in-stent restenosis,including TIA and stroke,even death.
    NIH Stroke Scale （NIHSS）
    At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS
    Bathel index
    At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS, Bathel index
    modified RANKIN score.
    modified RANKIN score.

    Full Information

    First Posted
    December 20, 2016
    Last Updated
    December 29, 2016
    Sponsor
    Guangzhou University of Traditional Chinese Medicine
    Collaborators
    Liaocheng People's Hospital, Liaoning Tumor Hospital & Institute, Zhongshan People's Hospital, Guangdong, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03008798
    Brief Title
    Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117
    Acronym
    PRISIT
    Official Title
    Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117--PRISIT Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guangzhou University of Traditional Chinese Medicine
    Collaborators
    Liaocheng People's Hospital, Liaoning Tumor Hospital & Institute, Zhongshan People's Hospital, Guangdong, China

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal medicine C117--PRISIT Trial
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Occlusion and Stenosis of Unspecified Cerebral Artery
    Keywords
    Intracranial Artery, in-stent restenosis, Herbal Medicine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Herbal Medicine C-117
    Arm Type
    Experimental
    Arm Description
    Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
    Arm Title
    The Placebo of Herbal Medicine C-117
    Arm Type
    Placebo Comparator
    Arm Description
    The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
    Intervention Type
    Drug
    Intervention Name(s)
    Herbal Medicine C-117
    Intervention Description
    C117 formula including 2 herbals and 2 insects
    Intervention Type
    Drug
    Intervention Name(s)
    The Placebo of Herbal Medicine C-117
    Primary Outcome Measure Information:
    Title
    the total number of all-cause mortality and all-cause stroke within 12 months
    Description
    After drug-use 12 months,observe all-cause mortality and all-cause stroke（hemorrhage or ischemic）.
    Time Frame
    After 12 months follow-up
    Secondary Outcome Measure Information:
    Title
    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.
    Time Frame
    After 12 months follow-up period,record the rate of intracranial in-stent restenosis
    Title
    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.
    Time Frame
    After 12 months follow-up period,record the complications of intracranial in-stent restenosis
    Title
    NIH Stroke Scale （NIHSS）
    Description
    At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS
    Time Frame
    After 12 months follow-up period
    Title
    Bathel index
    Description
    At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS, Bathel index
    Time Frame
    After 12 months follow-up period
    Title
    modified RANKIN score.
    Description
    modified RANKIN score.
    Time Frame
    After 12 months follow-up period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Older than 18 years of age 70-90% stenosis of intracranial responsible angiopathic area under the DSA angiography (as judged through the WASID method);after operation vascular stenosis less than 50%. The score of mRS≤3 To rule out intracranial hemorrhage by CT orMRI Adhere to the medication Exclusion Criteria： Together with intracranial tumors or AVM The lesion area where implant stent previons Fetch intracranial artery thrombus by emergency surgical operation Vascular serious circuity Myocardial infarction need to antithrombotic MoyaMoya disease or cerebral vasculitis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jianwen Guo, doctor
    Phone
    0086-13724899379
    Email
    jianwen_guo@msn.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    jianwen guo, MD
    Phone
    (08620)81887233
    Ext
    30906
    Email
    306247680@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yingguang Zhang, MD
    Organizational Affiliation
    Guangdong Province Hospital of Tradtional Chinese Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Zhangyong Xia, MD
    Organizational Affiliation
    Liaocheng People's Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jian Yang, MD
    Organizational Affiliation
    Liaoning Tumor Hospital & Institute
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Wentong Ling, MD
    Organizational Affiliation
    Zhangshan People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117

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