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
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
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
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
NCT ID
NCT03008798
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
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
Learn more about this trial
Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117
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