Menu
Recruiting NCT03753555

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

Phase IV Interventional Stroke, Ischemic Atherosclerosis, Cerebral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atorvastatin Calcium, Atorvastatin Calcium, Probucol, PCSK9 inhibitor.
Who it may be relevant to
Registry conditions: Stroke, Ischemic, Atherosclerosis, Cerebral. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Changes in remodeling index after the statin treatment [Time frame: baseline, 6 months, 12 months after treatment]
  • Changes in plaque burden after the statin treatment [Time frame: baseline, 6 months, 12 months after treatment]
  • Changes plaque composition in after the statin treatment [Time frame: baseline, 6 months, 12 months after treatment]
Secondary outcome measures (9)
  • level of serum bio-markers compared with baseline [Time frame: 6 months]
  • level of serum bio-markers compared with baseline [Time frame: 12 months]
  • mRS (0-2) [Time frame: 6 months]
  • mRS (0-2) [Time frame: 12 months]
  • vascular events [Time frame: 6 months]
  • vascular events [Time frame: 12 months]
  • abnormal test data [Time frame: 12 months]
  • any adverse event [Time frame: 12 months]
  • death of any causes [Time frame: 12months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • General Hospital of ShenYang Military Region — Shenyang

Identifiers

NCT: NCT03753555 · k（2018）44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗