Occlusion and Stenosis of Unspecified Cerebral ArteryPhase 2PRISITNCT03008798
Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117
A Phase 2 study testing Herbal Medicine C-117 in people with Occlusion and Stenosis of Unspecified Cerebral Artery, run by Guangzhou University of Traditional Chinese Medicine.
Trial summary
Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal medicine C117--PRISIT Trial Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Occlusion and Stenosis of Unspecified Cerebral Artery
- What is being tested?
- Herbal Medicine C-117
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years of age
- 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%.
- The score of mRS≤3
- To rule out intracranial hemorrhage by CT orMRI
- Adhere to the medication
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Being tested
- Herbal Medicine C-117, The Placebo of Herbal Medicine C-117
- Keywords
- Intracranial Artery, in-stent restenosis, Herbal Medicine
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal Medicine C-117Drug
C117 formula including 2 herbals and 2 insects
The Placebo of Herbal Medicine C-117Drug
| Study group | Role | What they receive |
|---|---|---|
| Herbal Medicine C-117 | Experimental | Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year Receives: Drug: Herbal Medicine C-117 |
| The Placebo of Herbal Medicine C-117 | Placebo comparator | The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year Receives: Drug: The Placebo of Herbal Medicine C-117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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）.
Measured: After 12 months follow-up
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: After 12 months follow-up period
modified RANKIN score.
modified RANKIN score.
Measured: After 12 months follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusion and Stenosis of Unspecified Cerebral ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Liaocheng People's Hospital, Liaoning Cancer Hospital & Institute, Zhongshan People's Hospital, Guangdong, China
- Responsible party
- Principal investigator, jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine
- Investigators
- Yingguang Zhang, MD, Principal investigator, Guangdong Province Hospital of Tradtional Chinese MedicineZhangyong Xia, MD, Principal investigator, Liaocheng People's HospitalJian Yang, MD, Principal investigator, Liaoning Cancer Hospital & InstituteWentong Ling, MD, Principal investigator, Zhangshan People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008798
- Sponsor's protocol ID
- 2014A020221074
- Acronym
- PRISIT
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117--PRISIT Trial
- ClinicalTrials.gov ID
- NCT03008798
- Acronym / sponsor ID
- PRISIT / 2014A020221074
- Keywords
- Intracranial Artery, in-stent restenosis, Herbal Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Liaocheng People's Hospital, Liaoning Cancer Hospital & Institute, Zhongshan People's Hospital, Guangdong, China
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal medicine C117--PRISIT Trial
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herbal Medicine C-117 | Experimental | Drug: Herbal Medicine C-117Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year |
| The Placebo of Herbal Medicine C-117 | Placebo comparator | Drug: The Placebo of Herbal Medicine C-117The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older than 18 years of age
- 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%.
- The score of mRS≤3
- To rule out intracranial hemorrhage by CT orMRI
- Adhere to the medication
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal Medicine C-117C117 formula including 2 herbals and 2 insects | Drug | Herbal Medicine C-117 |
| The Placebo of Herbal Medicine C-117 | Drug | The Placebo of Herbal Medicine C-117 |
Primary outcome
the total number of all-cause mortality and all-cause stroke within 12 months
Time frame: After 12 months follow-up
After drug-use 12 months,observe all-cause mortality and all-cause stroke（hemorrhage or ischemic）.
5 secondary outcomes
The rate of intracranial in-stent restenosis
Time frame: After 12 months follow-up period,record the rate of intracranial in-stent restenosis
The complications of intracranial in-stent restenosis
Time frame: After 12 months follow-up period,record the complications of intracranial in-stent restenosis
NIH Stroke Scale （NIHSS）
Time frame: After 12 months follow-up period
Bathel index
Time frame: After 12 months follow-up period
modified RANKIN score.
Time frame: After 12 months follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingguang Zhang, MD principal investigator
Guangdong Province Hospital of Tradtional Chinese Medicine
Zhangyong Xia, MD principal investigator
Liaocheng People's Hospital
Jian Yang, MD principal investigator
Liaoning Cancer Hospital & Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herbal Medicine C-117 in people with Occlusion and Stenosis of Unspecified Cerebral Artery, run by Guangzhou University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianwen Guo, doctor (0086-13724899379, jianwen_guo@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total number of all-cause mortality and all-cause stroke within 12 months (time frame: After 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2017.