The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques
NCT03753555 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-04-27
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.
Conditions
- Stroke, Ischemic
- Atherosclerosis, Cerebral
Interventions
- DRUG
-
Atorvastatin Calcium
20mg Qd for 12 months
- DRUG
-
Atorvastatin Calcium
40-80mg Qd for 6 months
- DRUG
-
Probucol
0.5g Bid for 6 months
- DRUG
-
PCSK9 inhibitor
Evolocumab 140mg subcutaneously injected, twice each month
Sponsors & Collaborators
-
General Hospital of Shenyang Military Region
lead OTHER
Principal Investigators
-
Huisheng Chen, Doctor · Neurology Department
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-01
- Primary Completion
- 2027-11-30
- Completion
- 2027-11-30
Countries
- China
Study Locations
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