Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03008798
Other study ID # 2014A020221074
Secondary ID
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


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