Intensive statin therapy for 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

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
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (Academic / other)
• Locations: 1 site (Shenyang)
• Trial ID: NCT03753555 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with intracranial hemorrhage, cardioembolic stroke origins, or severe hepatic or renal dysfunction are unlikely to benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Shenyang

• General Hospital of ShenYang Military Region — Shenyang, China (Recruiting)

Study contacts

• Study coordinator: Xinhong Wang, Doctor

Conditions Stroke, Ischemic; Atherosclerosis, Cerebral