Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117
PRISIT
1 other identifier
interventional
180
0 countries
N/A
Brief Summary
Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal medicine C117--PRISIT Trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2017
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedFirst Posted
Study publicly available on registry
January 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 2, 2017
December 1, 2016
2.9 years
December 20, 2016
December 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
The rate of intracranial in-stent restenosis
After 12 months follow-up period,record the rate of intracranial in-stent restenosis
The complications of intracranial in-stent restenosis
After 12 months follow-up period,record the complications of intracranial in-stent restenosis
NIH Stroke Scale （NIHSS）
After 12 months follow-up period
Bathel index
After 12 months follow-up period
modified RANKIN score.
After 12 months follow-up period
Study Arms (2)
Herbal Medicine C-117
EXPERIMENTALHerbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
The Placebo of Herbal Medicine C-117
PLACEBO COMPARATORThe Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
Interventions
Eligibility Criteria
You may qualify if:
- Older than 18 years of age
- % 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guangzhou University of Traditional Chinese Medicinelead
- Liaocheng People's Hospitalcollaborator
- Liaoning Cancer Hospital & Institutecollaborator
- Zhongshan People's Hospital, Guangdong, Chinacollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Cancer Hospital & Institute
- PRINCIPAL INVESTIGATOR
Wentong Ling, MD
Zhangshan People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 20, 2016
First Posted
January 2, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
January 2, 2017
Record last verified: 2016-12