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

NCT ID: NCT03753555

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2026-11-30

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.

Conditions

Stroke, Ischemic; Atherosclerosis, Cerebral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Routine-dose statin group

Routine-dose statin group will be gaven the treatment of atorvastatin 20mg Qd for 12 months

Group Type: ACTIVE_COMPARATOR

Atorvastatin Calcium

Intervention Type: DRUG

20mg Qd for 12 months

high-dose statin or PCSK9 inhibitor group

high-dose statin group will be gaven the treatment of atorvastatin 40-80mg Qd till 6 months at the moment the subjects will be followed up to determine plaques status by HRMRI examination, among which the subjects presenting culprit plaque progression with the significant increasing of plaque burden including intraplaque hemorrhage will be again randomized into two groups at a ratio of 1:1 as followed: atorvastatin-probucol group will be administrated atorvastatin 40-80mg Qd plus probucol 0.5g Bid till 12 months, the other group will maintain the original scheme till 12 months.

PCSK9 inhibitor group will receive the subcutaneous injection of Evolocumab (140mg, 2 / month) for one year.

Group Type: EXPERIMENTAL

Atorvastatin Calcium

Intervention Type: DRUG

40-80mg Qd for 6 months

Probucol

Intervention Type: DRUG

0.5g Bid for 6 months

PCSK9 inhibitor

Intervention Type: DRUG

Evolocumab 140mg subcutaneously injected, twice each month

Interventions

Atorvastatin Calcium

20mg Qd for 12 months

Intervention Type: DRUG

Atorvastatin Calcium

40-80mg Qd for 6 months

Intervention Type: DRUG

Probucol

0.5g Bid for 6 months

Intervention Type: DRUG

PCSK9 inhibitor

Evolocumab 140mg subcutaneously injected, twice each month

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Department Chairman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huisheng Chen, Doctor

Role: STUDY_CHAIR

Neurology Department

Locations

General Hospital of ShenYang Military Region

Shenyang, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinhong Wang, Doctor

Role: CONTACT

450341972@qq.com

15309885658 ext. 024-28897512

Yu Cui, Master

Role: CONTACT

314486939@qq.com

18842398646 ext. 024-28897512

Facility Contacts

Cheng Xia, Ph.D

Role: primary

xiacheng1975@sina.com

Other Identifiers

k（2018）44

Identifier Type: -

Identifier Source: org_study_id