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

Guangzhou University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 2

Conditions: Occlusion and Stenosis of Unspecified Cerebral Artery

Treatments: Drug: The Placebo of Herbal Medicine C-117; Drug: Herbal Medicine C-117

Study type: Interventional

Funder types: Other

Identifiers

NCT03008798

2014A020221074

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Herbal Medicine C-117

Experimental group

Description:

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

Treatment:

Drug: Herbal Medicine C-117

The Placebo of Herbal Medicine C-117

Placebo Comparator group

Description:

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

Treatment:

Drug: The Placebo of Herbal Medicine C-117