Stroke, Ischemic, Atherosclerosis, Cerebral
Conditions
Brief 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. 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.
Interventions
DRUGProbucol
0.5g Bid for 6 months
DRUGAtorvastatin Calcium
20mg Qd for 12 months
DRUGPCSK9 inhibitor
Evolocumab 140mg subcutaneously injected, twice each month
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient age between 18-80 years 2. Time of onset: within 1 week 3. NIHSS score ≤12 4. Acute ischemic stroke confirmed by head CT or MRI 5. Premorbid mRS ≤1 6. The degree of stenosis of carotid artery, vertebral artery and intracranial portion of internal carotid artery on the lesion side \<50% 7. 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 8. Signed informed consent
Exclusion criteria
1. Intracranial hemorrhage found by head CT 2. Stroke attributable to cardioembolic origin (atrial fibrillation, valvular heart disease, aortic arch atherosclerosis) 3. Severe hepatic or renal dysfunction 4. Pregnant females 5. Abnormal elevation of creatine phosphokinase 6. Expected stent angioplasty 7. Blood sugar is out of control 8. Receiving statins within 1 month before onset 9. Obstinate hypertension with more than 140/90 mmHg after medication 10. Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures 11. Unsuitable for this clinical studies assessed by researcher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in remodeling index after the statin treatment | 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 | 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 | baseline, 6 months, 12 months after treatment | plaque composition: lipid core and fiber tissue of plaque on high-resolution MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| abnormal test data | 12 months | incidence of abnormal liver function or muscle enzyme levels |
| level of serum bio-markers compared with baseline | 6 months | Serum level of LDL、hs-CRP、sLOX1 and oxLDL |
| death of any causes | 12months | proportion of death |
| any adverse event | 12 months | incidence of adverse event |
| mRS (0-2) | 6 months | proportion of mRS (0-2) |
| vascular events | 6 months | incidence of Transient ischemic attack, stroke or other vascular events |
Countries
China
Contacts
Primary ContactXinhong Wang, Doctor
Backup ContactYu Cui, Master
Outcome results
None listed