Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117--PRISIT Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 180
- 主要终点
- the total number of all-cause mortality and all-cause stroke within 12 months
研究概览
简要总结
Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal medicine C117--PRISIT Trial
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Herbal Medicine C-117
Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
干预措施: Herbal Medicine C-117 (Drug)
The Placebo of Herbal Medicine C-117
The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
干预措施: The Placebo of Herbal Medicine C-117 (Drug)
结局指标
主要结局
the total number of all-cause mortality and all-cause stroke within 12 months
时间窗: After 12 months follow-up
After drug-use 12 months,observe all-cause mortality and all-cause stroke（hemorrhage or ischemic）.
次要结局
- The rate of intracranial in-stent restenosis(After 12 months follow-up period,record the rate of intracranial in-stent restenosis)
- NIH Stroke Scale （NIHSS）(After 12 months follow-up period)
- The complications of intracranial in-stent restenosis(After 12 months follow-up period,record the complications of intracranial in-stent restenosis)
- Bathel index(After 12 months follow-up period)
- modified RANKIN score.(After 12 months follow-up period)
研究者
jianwen guo, MD
Professor
Guangzhou University of Traditional Chinese Medicine