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NCT Number: NCT03753555

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

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.

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Key information

Conditions

Stroke, Ischemic Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis, Cerebral Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Intracranial Arteriosclerosis Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital of ShenYang Military Region

Shenyang, China

Location status: Recruiting

Location contact

Cheng Xia, Ph.D

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin calcium

Drug

20mg Qd for 12 months

Probucol

Drug

0.5g Bid for 6 months

PCSK9 inhibitor

Drug

Evolocumab 140mg subcutaneously injected, twice each month

Primary outcomes

  1. Changes in remodeling index after the statin treatment

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

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

  2. Changes in plaque burden after the statin treatment

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

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

  3. Changes plaque composition in after the statin treatment

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

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

Secondary outcomes

  1. level of serum bio-markers compared with baseline

    Time frame: 6 months

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

  2. level of serum bio-markers compared with baseline

    Time frame: 12 months

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

  3. mRS (0-2)

    Time frame: 6 months

    proportion of mRS (0-2)

  4. mRS (0-2)

    Time frame: 12 months

    proportion of mRS (0-2)

  5. vascular events

    Time frame: 6 months

    incidence of Transient ischemic attack, stroke or other vascular events

  6. vascular events

    Time frame: 12 months

    incidence of Transient ischemic attack, stroke or other vascular events

  7. abnormal test data

    Time frame: 12 months

    incidence of abnormal liver function or muscle enzyme levels

  8. any adverse event

    Time frame: 12 months

    incidence of adverse event

  9. death of any causes

    Time frame: 12months

    proportion of death

Study contacts

Contact information is provided by the study sponsor or research team.

Xinhong Wang, Doctor

CONTACT

[email protected]

15309885658 ext. 024-28897512

Yu Cui, Master

CONTACT

[email protected]

18842398646 ext. 024-28897512

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study 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

Acronym: INSIST-HRMRI

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Nov 27, 2018
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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