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

Who is this study for? Adult patients with Ischemic Stroke
What treatments are being studied? Atorvastatin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
General Hospital of ShenYang Military Region
RECRUITING
Shenyang
Contact Information
Primary
Xinhong Wang, Doctor
450341972@qq.com
15309885658
Backup
Yu Cui, Master
314486939@qq.com
18842398646
Time Frame
Start Date: 2018-12-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 100
Treatments
Active_comparator: Routine-dose statin group
Routine-dose statin group will be gaven the treatment of atorvastatin 20mg Qd for 12 months
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: General Hospital of Shenyang Military Region

This content was sourced from clinicaltrials.gov