The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques

Stroke, Ischemic Clinical Trial

— INSIST-HRMRI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03753555
• Other study ID #: k(2018)44
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis, Cerebral
• Intracranial Arteriosclerosis
• Ischemia
• Ischemic Stroke
• Plaque, Atherosclerotic
• Stroke
• Stroke, Ischemic

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