Stroke, IschemicPhase 4INSIST-HRMRINCT03753555
The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques
A Phase 4 study testing Atorvastatin Calcium, Probucol and PCSK9 inhibitor in people with Stroke, Ischemic and Atherosclerosis, Cerebral, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Intracranial atherosclerotic disease is the most common cause of ischemic stroke that is directly attributed to the progression or rupture of intracranial high-risk plaque in Asia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Ischemic, Atherosclerosis, Cerebral
- What is being tested?
- Atorvastatin Calcium, Probucol and PCSK9 inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 30 Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patient age between 18-80 years
- Time of onset: within 1 week
- NIHSS score ≤12
- Acute ischemic stroke confirmed by head CT or MRI
- Premorbid mRS ≤1
- The degree of stenosis of carotid artery, vertebral artery and intracranial portion of internal carotid artery on the lesion side <50%
- The culprit plaque or possible culprit plaque with plaque burden of 40% or more found by HRMRI in the proximal part of the middle cerebral artery M1 segment or basilar artery of ipsilateral lesion
- Signed informed consent
Who cannot join
- Intracranial hemorrhage found by head CT
- Stroke attributable to cardioembolic origin (atrial fibrillation, valvular heart disease, aortic arch atherosclerosis)
- Severe hepatic or renal dysfunction
- Pregnant females
- Abnormal elevation of creatine phosphokinase
- Expected stent angioplasty
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- Blood sugar is out of control
- Receiving statins within 1 month before onset
- Obstinate hypertension with more than 140/90 mmHg after medication
- Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures
- Unsuitable for this clinical studies assessed by researcher
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of ShenYang Military Region
Shenyang
Cheng Xia, Ph.D, xiacheng1975@sina.com
About this study
Official title: The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques: a Prospective, Random, Single-center Study Based on High Resolution Magnetic Resonance Imaging
Intracranial atherosclerotic disease is the most common cause of ischemic stroke that is directly attributed to the progression or rupture of intracranial high-risk plaque in Asia. Many studies mainly from Euro-American population with a focus on extracranial carotid plaque have fully demonstrated the advantages of intensive statin therapy on stabilizing or reversing plaque burden, reversing plaque composition presenting that lipid-rich necrotic core (LRNC) is gradually replaced by fibrous tissue, and even reversing pattern of arterial remodeling to reduce the occurrence of cerebrovascular events. Yet, direct evidence of the effect of intensive statin therapy on intracranial atherosclerotic plaques is lacking and the effect of statin intensity and duration on intracranial plaque burden and composition is still unclear. High resolution magnetic resonance imaging (HRMRI) is a new and non-invasive technique that enable to assess the morphologic characteristics of vascular wall and plaque composition of intracranial artery. Based on above discussion, the investigators conduct this study to further determine the effect of intensive statin in ischemic stroke with intracranial atherosclerotic plaques.
- Conditions
- Stroke, Ischemic, Atherosclerosis, Cerebral
- Being tested
- Atorvastatin Calcium, Probucol, PCSK9 inhibitor
- Medical subject headings
- Ischemic Stroke, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin CalciumDrug
20mg Qd for 12 months
Atorvastatin CalciumDrug
40-80mg Qd for 6 months
ProbucolDrug
0.5g Bid for 6 months
PCSK9 inhibitorDrug
Evolocumab 140mg subcutaneously injected, twice each month
| Study group | Role | What they receive |
|---|---|---|
| Routine-dose statin group | Active comparator | Routine-dose statin group will be gaven the treatment of atorvastatin 20mg Qd for 12 months Receives: Drug: Atorvastatin Calcium |
| high-dose statin or PCSK9 inhibitor group | Experimental | high-dose statin group will be gaven the treatment of atorvastatin 40-80mg Qd till 6 months at the moment the subjects will be followed up to determine plaques status by HRMRI examination, among which the subjects presenting culprit plaque progression with the significant increasing of plaque burden including intraplaque hemorrhage will be again randomized into two groups at a ratio of 1:1 as followed: atorvastatin-probucol group will be administrated atorvastatin 40-80mg Qd plus probucol 0.5g Bid till 12 months, the other group will maintain the original scheme till 12 months.
PCSK9 inhibitor group will receive the subcutaneous injection of Evolocumab (140mg, 2 / month) for one year. Receives: Drug: Atorvastatin Calcium; Drug: Probucol; Drug: PCSK9 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in remodeling index after the statin treatment
remodeling index: crimed vessel area/normal vessel area on high-resolution MRI
Measured: baseline, 6 months, 12 months after treatment
Changes in plaque burden after the statin treatment
plaque burden: crimed vessel wall area/crimed vessel area on high-resolution MRI
Measured: baseline, 6 months, 12 months after treatment
Changes plaque composition in after the statin treatment
plaque composition: lipid core and fiber tissue of plaque on high-resolution MRI
Measured: baseline, 6 months, 12 months after treatment
Secondary outcomes (9)
level of serum bio-markers compared with baseline
Serum level of LDL、hs-CRP、sLOX1 and oxLDL
Measured: 6 months
level of serum bio-markers compared with baseline
Serum level of LDL、hs-CRP、sLOX1 and oxLDL
Measured: 12 months
mRS (0-2)
proportion of mRS (0-2)
Measured: 6 months
mRS (0-2)
proportion of mRS (0-2)
Measured: 12 months
vascular events
incidence of Transient ischemic attack, stroke or other vascular events
Measured: 6 months
vascular events
incidence of Transient ischemic attack, stroke or other vascular events
Measured: 12 months
abnormal test data
incidence of abnormal liver function or muscle enzyme levels
Measured: 12 months
any adverse event
incidence of adverse event
Measured: 12 months
death of any causes
proportion of death
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Dec 2018
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
- Investigators
- Huisheng Chen, Doctor, Study chair, Neurology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753555
- Sponsor's protocol ID
- k（2018）44
- Acronym
- INSIST-HRMRI
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2018
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques: a Prospective, Random, Single-center Study Based on High Resolution Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03753555
- Acronym / sponsor ID
- INSIST-HRMRI / k（2018）44
- Conditions
- Stroke, Ischemic, Atherosclerosis, Cerebral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 27 Nov 2018 (actual)
- 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.
Intracranial atherosclerotic disease is the most common cause of ischemic stroke that is directly attributed to the progression or rupture of intracranial high-risk plaque in Asia. Many studies mainly from Euro-American population with a focus on extracranial carotid plaque have fully demonstrated the advantages of intensive statin therapy on stabilizing or reversing plaque burden, reversing plaque composition presenting that lipid-rich necrotic core (LRNC) is gradually replaced by fibrous tissue, and even reversing pattern of arterial remodeling to reduce the occurrence of cerebrovascular events. Yet, direct evidence of the effect of intensive statin therapy on intracranial atherosclerotic plaques is lacking and the effect of statin intensity and duration on intracranial plaque burden and composition is still unclear. High resolution magnetic resonance imaging (HRMRI) is a new and non-invasive technique that enable to assess the morphologic characteristics of vascular wall and plaque composition of intracranial artery. Based on above discussion, the investigators conduct this study to further determine the effect of intensive statin in ischemic stroke with intracranial atherosclerotic plaques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine-dose statin group | Active comparator | Drug: Atorvastatin CalciumRoutine-dose statin group will be gaven the treatment of atorvastatin 20mg Qd for 12 months |
| high-dose statin or PCSK9 inhibitor group | Experimental | Drug: Atorvastatin Calcium, Drug: Probucol, Drug: PCSK9 inhibitorhigh-dose statin group will be gaven the treatment of atorvastatin 40-80mg Qd till 6 months at the moment the subjects will be followed up to determine plaques status by HRMRI examination, among which the subjects presenting culprit plaque progression with the significant increasing of plaque burden including intraplaque hemorrhage will be again randomized into two groups at a ratio of 1:1 as followed: atorvastatin-probucol group will be administrated atorvastatin 40-80mg Qd plus probucol 0.5g Bid till 12 months, the other group will maintain the original scheme till 12 months. PCSK9 inhibitor group will receive the subcutaneous injection of Evolocumab (140mg, 2 / month) for one year. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient age between 18-80 years
- Time of onset: within 1 week
- NIHSS score ≤12
- Acute ischemic stroke confirmed by head CT or MRI
- Premorbid mRS ≤1
Key exclusion criteria (11 listed)
- Intracranial hemorrhage found by head CT
- Stroke attributable to cardioembolic origin (atrial fibrillation, valvular heart disease, aortic arch atherosclerosis)
- Severe hepatic or renal dysfunction
- Pregnant females
- Abnormal elevation of creatine phosphokinase
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 |
|---|---|---|
| Atorvastatin Calcium20mg Qd for 12 months | Drug | Routine-dose statin group |
| Atorvastatin Calcium40-80mg Qd for 6 months | Drug | high-dose statin or PCSK9 inhibitor group |
| Probucol0.5g Bid for 6 months | Drug | high-dose statin or PCSK9 inhibitor group |
| PCSK9 inhibitorEvolocumab 140mg subcutaneously injected, twice each month | Drug | high-dose statin or PCSK9 inhibitor group |
Primary outcome
Changes in remodeling index after the statin treatment
Time frame: baseline, 6 months, 12 months after treatment
remodeling index: crimed vessel area/normal vessel area on high-resolution MRI
Changes in plaque burden after the statin treatment
Time frame: baseline, 6 months, 12 months after treatment
plaque burden: crimed vessel wall area/crimed vessel area on high-resolution MRI
Changes plaque composition in after the statin treatment
Time frame: baseline, 6 months, 12 months after treatment
plaque composition: lipid core and fiber tissue of plaque on high-resolution MRI
9 secondary outcomes
level of serum bio-markers compared with baseline
Time frame: 6 months
level of serum bio-markers compared with baseline
Time frame: 12 months
mRS (0-2)
Time frame: 6 months
mRS (0-2)
Time frame: 12 months
vascular events
Time frame: 6 months
vascular events
Time frame: 12 months
abnormal test data
Time frame: 12 months
any adverse event
Time frame: 12 months
death of any causes
Time frame: 12months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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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.
Huisheng Chen, Doctor study chair
Neurology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin Calcium, Probucol and PCSK9 inhibitor in people with Stroke, Ischemic and Atherosclerosis, Cerebral, run by General Hospital of Shenyang Military Region at 1 site in China.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinhong Wang, Doctor (15309885658 ext. 024-28897512, 450341972@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in remodeling index after the statin treatment (time frame: baseline, 6 months, 12 months after treatment). The study lists 3 primary outcomes in all. 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 27 Apr 2026.