Improving blood lipid management for patients with symptomatic intracranial artery stenosis
A Prospective Observational Study on the Effect of Improving Blood Lipid Management on the Clinical Prognosis of Symptomatic Intracranial Atherosclerotic Stenosis（sICASBLM）
This study is testing whether adding a new type of cholesterol-lowering medication to standard treatment can help people with narrowed brain arteries reduce their chances of having another stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT05397405 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of combining conventional lipid management with PCSK9 inhibitors in patients suffering from moderate to severe symptomatic intracranial atherosclerotic stenosis. Participants will receive either standard statin therapy or the combination treatment to assess the impact on reducing recurrent stroke incidence. The study focuses on patients with elevated LDL cholesterol levels who have not undergone endovascular therapy. The goal is to determine if enhanced lipid management can lead to better clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate to severe symptomatic intracranial atherosclerotic stenosis and elevated LDL cholesterol levels.
Not a fit: Patients with contraindications to statins or MRI examinations, as well as those with severe comorbidities or specific vascular conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of recurrent strokes in patients with symptomatic intracranial artery stenosis.
How similar studies have performed: While the combination of lipid management strategies is being explored, this specific approach using PCSK9 inhibitors in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years 2. Symptomatic intracranial atherosclerotic stenosis of moderate to severe, did not receive intravenous thrombolysis, thrombectomy, stent implantation and other intravascular treatment 3. low density lipoprotein cholesterol \> 70mg/dl (1.8mmol/L) 4. Receive 3T magnetic resonance angiography or multi-mode MR (high resolution is required), angiography can be included, and images for analysis can be obtained. 5. Lipid-lowering indications of statins 6. Signed an approved informed consents Exclusion Criteria: 1. Contraindications to statins 2. There are contraindications to MRI examination or cannot accept MRI examination 3. Stenosis caused by vasculitis, arterial dissection and moyamoya disease 4. Patients with active bleeding or obvious bleeding tendency 5. Severe heart, lung, renal insufficiency, malignant tumor or other malignant diseases, and death is highly likely within 7 days; pregnancy or women who are lactating 6. Uncontrolled severe diabetes and hypertension 7. Other conditions inappropriate for inclusion judged by investigators
Where this trial is running
Nanjing, Jiangsu and 1 other locations
- Nanjing First Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
- Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Junshan Zhou
- Email: zhjsh333@126.com
- Phone: 8602587726218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.