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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03753555
Other study ID # k(2018)44
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 1, 2018
Est. completion date November 30, 2024

Study information

Verified date February 2024
Source General Hospital of Shenyang Military Region
Contact Xinhong Wang, Doctor
Phone 15309885658
Email 450341972@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Drug:
Atorvastatin Calcium
20mg Qd for 12 months
Atorvastatin Calcium
40-80mg Qd for 6 months
Probucol
0.5g Bid for 6 months
PCSK9 inhibitor
Evolocumab 140mg subcutaneously injected, twice each month

Locations

Country Name City State
China General Hospital of ShenYang Military Region ShenYang

Sponsors (1)

Lead Sponsor Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in remodeling index after the statin treatment remodeling index: crimed vessel area/normal vessel area on high-resolution MRI baseline, 6 months, 12 months after treatment
Primary Changes in plaque burden after the statin treatment plaque burden: crimed vessel wall area/crimed vessel area on high-resolution MRI baseline, 6 months, 12 months after treatment
Primary Changes plaque composition in after the statin treatment plaque composition: lipid core and fiber tissue of plaque on high-resolution MRI baseline, 6 months, 12 months after treatment
Secondary level of serum bio-markers compared with baseline Serum level of LDL?hs-CRP?sLOX1 and oxLDL 6 months
Secondary level of serum bio-markers compared with baseline Serum level of LDL?hs-CRP?sLOX1 and oxLDL 12 months
Secondary mRS (0-2) proportion of mRS (0-2) 6 months
Secondary mRS (0-2) proportion of mRS (0-2) 12 months
Secondary vascular events incidence of Transient ischemic attack, stroke or other vascular events 6 months
Secondary vascular events incidence of Transient ischemic attack, stroke or other vascular events 12 months
Secondary abnormal test data incidence of abnormal liver function or muscle enzyme levels 12 months
Secondary any adverse event incidence of adverse event 12 months
Secondary death of any causes proportion of death 12months
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