Intensive statin therapy for ischemic stroke with intracranial atherosclerotic plaques
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
Run by General Hospital of Shenyang Military Region · NCT03753555 · Data updated 2026-11-12
This study is testing whether stronger doses of statin medication can help people who have had an ischemic stroke due to plaque buildup in their brain arteries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Locations | 1 site (Shenyang) |
| Status | Recruiting |
| Started | December 1, 2018 |
| Main results expected | November 30, 2027 |
| Study ends | November 30, 2027 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT03753555 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-80 who have experienced an acute ischemic stroke within the past week and have specific imaging findings indicating intracranial plaque burden.
✕Probably not a fit
Patients with intracranial hemorrhage, cardioembolic stroke origins, or severe hepatic or renal dysfunction are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of intensive statin therapy on patients who have experienced an ischemic stroke due to intracranial atherosclerotic plaques. The study aims to determine how different intensities and durations of statin treatment influence the burden and composition of these plaques, which are assessed using high-resolution magnetic resonance imaging (HRMRI). By focusing on a population in Asia, the trial seeks to fill the gap in existing research that primarily addresses extracranial carotid plaques in Euro-American populations. The goal is to provide direct evidence on the efficacy of statins in stabilizing or reversing intracranial plaque progression.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from ischemic strokes caused by intracranial atherosclerosis.
How similar studies have gone: While studies have shown the benefits of intensive statin therapy for extracranial plaques, this approach for intracranial atherosclerotic plaques is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient age between 18-80 years 2. Time of onset: within 1 week 3. NIHSS score ≤12 4. Acute ischemic stroke confirmed by head CT or MRI 5. Premorbid mRS ≤1 6. The degree of stenosis of carotid artery, vertebral artery and intracranial portion of internal carotid artery on the lesion side \<50% 7. 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 8. Signed informed consent Exclusion Criteria: 1. Intracranial hemorrhage found by head CT 2. Stroke attributable to cardioembolic origin (atrial fibrillation, valvular heart disease, aortic arch atherosclerosis) 3. Severe hepatic or renal dysfunction 4. Pregnant females 5. Abnormal elevation of creatine phosphokinase 6. Expected stent angioplasty 7. Blood sugar is out of control 8. Receiving statins within 1 month before onset 9. Obstinate hypertension with more than 140/90 mmHg after medication 10. Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures 11. Unsuitable for this clinical studies assessed by researcher
Where it's running
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General Hospital of ShenYang Military Region
Shenyang, China Recruiting
Study contacts
- Study coordinator: Xinhong Wang, Doctor
- Email: 450341972@qq.com
- Phone: 15309885658
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.