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

NCT03753555 | Recruiting Phase 4 DMC

• 1 other identifier: k（2018）44
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (9)

• level of serum bio-markers compared with baseline

  6 months

• level of serum bio-markers compared with baseline

  12 months

• mRS (0-2)

  6 months

• mRS (0-2)

  12 months

• vascular events

  6 months

Study Arms (2)

Routine-dose statin group

ACTIVE COMPARATOR

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

Drug: Atorvastatin Calcium

high-dose statin or PCSK9 inhibitor group

EXPERIMENTAL

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.

Drug: Atorvastatin Calcium; Drug: Probucol; Drug: PCSK9 inhibitor

Interventions

Atorvastatin Calcium DRUG

20mg Qd for 12 months

Routine-dose statin group

Probucol DRUG

0.5g Bid for 6 months

high-dose statin or PCSK9 inhibitor group

PCSK9 inhibitor DRUG

Evolocumab 140mg subcutaneously injected, twice each month

high-dose statin or PCSK9 inhibitor group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age between 18-80 years
• Time of onset: within 1 week
• NIHSS score ≤12
• Acute ischemic stroke confirmed by head CT or MRI
• Premorbid mRS ≤1
• The degree of stenosis of carotid artery, vertebral artery and intracranial portion of internal carotid artery on the lesion side \<50%
• 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
• Signed informed consent

You may not qualify if:

• Intracranial hemorrhage found by head CT
• Stroke attributable to cardioembolic origin (atrial fibrillation, valvular heart disease, aortic arch atherosclerosis)
• Severe hepatic or renal dysfunction
• Pregnant females
• Abnormal elevation of creatine phosphokinase
• Expected stent angioplasty
• Blood sugar is out of control
• Receiving statins within 1 month before onset
• Obstinate hypertension with more than 140/90 mmHg after medication
• Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures
• Unsuitable for this clinical studies assessed by researcher

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of ShenYang Military Region

Shenyang, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Arteriosclerosis

Interventions

Atorvastatin; Probucol

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Huisheng Chen, Doctor

  Neurology Department

  STUDY CHAIR

Central Study Contacts

Xinhong Wang, Doctor

CONTACT

15309885658; 450341972@qq.com

Yu Cui, Master

CONTACT

18842398646; 314486939@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chairman

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 27, 2018
• Study Start: December 1, 2018
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CN (1)