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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGeneral Hospital of Shenyang Military Region

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patient age between 18-80 years

Time of onset: within 1 week

NIHSS score ≤12

Acute ischemic stroke confirmed by head CT or MRI

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atorvastatin Calcium

    Drug

    20mg Qd for 12 months

  • Atorvastatin Calcium

    Drug

    40-80mg Qd for 6 months

  • Probucol

    Drug

    0.5g Bid for 6 months

  • PCSK9 inhibitor

    Drug

    Evolocumab 140mg subcutaneously injected, twice each month

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Routine-dose statin groupActive comparator 1 intervention
Group B: high-dose statin or PCSK9 inhibitor groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Changes in remodeling index after the statin treatment

remodeling index: crimed vessel area/normal vessel area on high-resolution MRI

Time frame
baseline, 6 months, 12 months after treatment
2

Changes in plaque burden after the statin treatment

plaque burden: crimed vessel wall area/crimed vessel area on high-resolution MRI

Time frame
baseline, 6 months, 12 months after treatment
3

Changes plaque composition in after the statin treatment

plaque composition: lipid core and fiber tissue of plaque on high-resolution MRI

Time frame
baseline, 6 months, 12 months after treatment

Secondary outcomes

1

level of serum bio-markers compared with baseline

Serum level of LDL、hs-CRP、sLOX1 and oxLDL

Time frame
6 months
2

level of serum bio-markers compared with baseline

Serum level of LDL、hs-CRP、sLOX1 and oxLDL

Time frame
12 months
3

mRS (0-2)

proportion of mRS (0-2)

Time frame
6 months
4

mRS (0-2)

proportion of mRS (0-2)

Time frame
12 months

Other outcomes

Sponsors and contacts

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