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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 thrombus treatment center of integrated chinese and western medicine
Zhongshan People's Hospital
Information provided by (Responsible Party):
jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine

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

Condition or disease Intervention/treatment Phase
Occlusion and Stenosis of Unspecified Cerebral Artery Drug: Herbal Medicine C-117 Drug: The Placebo of Herbal Medicine C-117 Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117--PRISIT Trial
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herbal Medicine

Arm Intervention/treatment
Experimental: Herbal Medicine C-117
Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
Drug: Herbal Medicine C-117
C117 formula including 2 herbals and 2 insects

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
Drug: The Placebo of Herbal Medicine C-117



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. modified RANKIN score. [ Time Frame: After 12 months follow-up period ]
    modified RANKIN score.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008798


Contacts
Contact: Jianwen Guo, doctor 0086-13724899379 jianwen_guo@msn.com
Contact: jianwen guo, MD (08620)81887233 ext 30906 306247680@qq.com

Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Liaocheng People's Hospital
Liaoning thrombus treatment center of integrated chinese and western medicine
Zhongshan People's Hospital
Investigators
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 thrombus treatment center of integrated chinese and western medicine
Principal Investigator: Wentong Ling, MD Zhangshan People's Hospital

Responsible Party: jianwen guo, MD, Professor, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03008798     History of Changes
Other Study ID Numbers: 2014A020221074
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016

Keywords provided by jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine:
Intracranial Artery
in-stent restenosis
Herbal Medicine

Additional relevant MeSH terms:
Intracranial Arteriosclerosis
Intracranial Embolism
Intracranial Thrombosis
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Embolism and Thrombosis
Thromboembolism
Embolism and Thrombosis