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

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ClinicalTrials.gov Identifier: NCT03008798
Recruitment Status : Not yet recruiting
First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Sponsor:
Collaborators:
Liaocheng People's Hospital
Liaoning Tumor Hospital & Institute
Zhongshan People's Hospital, Guangdong, China
Information provided by (Responsible Party):
jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE December 20, 2016
First Posted Date  ICMJE January 2, 2017
Last Update Posted Date January 2, 2017
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2016)
the total number of all-cause mortality and all-cause stroke within 12 months [ Time Frame: After 12 months follow-up ]
After drug-use 12 months,observe all-cause mortality and all-cause stroke(hemorrhage or ischemic).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2016)
  • The rate of intracranial in-stent restenosis [ Time Frame: After 12 months follow-up period,record 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 [ Time Frame: After 12 months follow-up period,record 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) [ Time Frame: After 12 months follow-up period ]
    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 ]
    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. [ Time Frame: After 12 months follow-up period ]
    modified RANKIN score.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117
Official Title  ICMJE Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117--PRISIT Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Occlusion and Stenosis of Unspecified Cerebral Artery
Intervention  ICMJE
  • Drug: Herbal Medicine C-117
    C117 formula including 2 herbals and 2 insects
  • Drug: The Placebo of Herbal Medicine C-117
Study Arms  ICMJE
  • Experimental: Herbal Medicine C-117
    Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
    Intervention: Drug: Herbal Medicine C-117
  • Placebo Comparator: The Placebo of Herbal Medicine C-117
    The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
    Intervention: Drug: The Placebo of Herbal Medicine C-117
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 29, 2016)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jianwen Guo, doctor 0086-13724899379 jianwen_guo@msn.com
Contact: jianwen guo, MD (08620)81887233 ext 30906 306247680@qq.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03008798
Other Study ID Numbers  ICMJE 2014A020221074
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine
Study Sponsor  ICMJE Guangzhou University of Traditional Chinese Medicine
Collaborators  ICMJE
  • Liaocheng People's Hospital
  • Liaoning Tumor Hospital & Institute
  • Zhongshan People's Hospital, Guangdong, China
Investigators  ICMJE
Principal Investigator: Yingguang Zhang, MD Guangdong Province Hospital of Tradtional Chinese Medicine
Principal Investigator: Zhangyong Xia, MD Liaocheng People's Hospital
Principal Investigator: Jian Yang, MD Liaoning Tumor Hospital & Institute
Principal Investigator: Wentong Ling, MD Zhangshan People's Hospital
PRS Account Guangzhou University of Traditional Chinese Medicine
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP