About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient age between 18-80 years
Time of onset: within 1 week
NIHSS score ≤12
Acute ischemic stroke confirmed by head CT or MRI
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Atorvastatin Calcium
Drug20mg Qd for 12 months
Atorvastatin Calcium
Drug40-80mg Qd for 6 months
Probucol
Drug0.5g Bid for 6 months
PCSK9 inhibitor
DrugEvolocumab 140mg subcutaneously injected, twice each month
Treatment groups
Trial outcomes
Primary outcomes
Changes in remodeling index after the statin treatment
remodeling index: crimed vessel area/normal vessel area on high-resolution MRI
Changes in plaque burden after the statin treatment
plaque burden: crimed vessel wall area/crimed vessel area on high-resolution MRI
Changes plaque composition in after the statin treatment
plaque composition: lipid core and fiber tissue of plaque on high-resolution MRI
Secondary outcomes
level of serum bio-markers compared with baseline
Serum level of LDL、hs-CRP、sLOX1 and oxLDL
level of serum bio-markers compared with baseline
Serum level of LDL、hs-CRP、sLOX1 and oxLDL
mRS (0-2)
proportion of mRS (0-2)
mRS (0-2)
proportion of mRS (0-2)
Sponsors and contacts
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