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

Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117--PRISIT Trial

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

Study Overview

• Status: Unknown
• Conditions: Occlusion and Stenosis of Unspecified Cerebral Artery
• Intervention / Treatment: Drug: Herbal Medicine C-117; Drug: The Placebo of Herbal Medicine C-117

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
• Enrollment (Anticipated): 180
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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）.	After 12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 12 months follow-up period,record the rate of intracranial in-stent restenosis
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.	After 12 months follow-up period,record the complications of intracranial in-stent restenosis
NIH Stroke Scale （NIHSS）	At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS	After 12 months follow-up period
Bathel index	At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS, Bathel index	After 12 months follow-up period
modified RANKIN score.	modified RANKIN score.	After 12 months follow-up period

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Collaborators: Liaoning Tumor Hospital & Institute; Zhongshan People's Hospital, Guangdong, China; Liaocheng 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 Tumor Hospital & Institute; Principal Investigator: Wentong Ling, MD, Zhangshan People's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 29, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Estimate): January 2, 2017
• Last Update Submitted That Met QC Criteria: December 29, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Herbal Medicine; in-stent restenosis; Intracranial Artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Intracranial Arterial Diseases; Intracranial Embolism and Thrombosis; Thromboembolism; Intracranial Arteriosclerosis; Intracranial Embolism; Intracranial Thrombosis
• Other Study ID Numbers: 2014A020221074