NCT03753555

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: General Hospital of Shenyang Military Region · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2018-12-01
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2018-11-27
• Last updated: 2025-03-18

Locations

1 site across 1 country: China