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

Occlusion and Stenosis of Unspecified Cerebral Artery Clinical Trial

— PRISIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03008798
• Other study ID #: 2014A020221074
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 20, 2016
• Last updated: December 29, 2016
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Jianwen Guo, doctor
• Phone: 0086-13724899379
• Email: jianwen_guo[@]msn.com
• Is FDA regulated: No
• Health authority: China:Guangdong Provincial Department of Science and Technology
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intracranial Arteriosclerosis
• Intracranial Embolism
• Intracranial Thrombosis
• Occlusion and Stenosis of Unspecified Cerebral Artery

Intervention

Drug:
• Herbal Medicine C-117
C117 formula including 2 herbals and 2 insects
• The Placebo of Herbal Medicine C-117

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine	Liaocheng People's Hospital, Liaoning thrombus treatment center of integrated chinese and western medicine, Zhongshan People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	modified RANKIN score.	modified RANKIN score.	After 12 months follow-up period	No