Improving Blood Lipid Management in Symptomatic Intracranial Atherosclerotic Stenosis on Clinical Outcome

NCT05397405 — Not applicable, Recruiting, 180 participants, Nanjing First Hospital, Nanjing Medical University

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A Prospective Observational Study on the Effect of Improving Blood Lipid Management on the Clinical Prognosis of Symptomatic Intracranial Atherosclerotic Stenosis（sICASBLM）

Registry	NCT05397405, acronym sICASBLM
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	180 (Estimated)
Sponsor	Nanjing First Hospital, Nanjing Medical University (Other)
Conditions	Intracranial Artery Stenosis
Interventions	PCSK9 inhibitor (Drug)
Dates	start 2022-05-23, primary completion 2026-05-01 (estimated), completion 2026-05-01 (estimated), first posted 2022-05-31, last updated 2026-04-15
Locations	2 sites in China

-Summary

sICASBLM is a prospective controlled trial, to asses the impact of improving blood lipid management on clinical outcome of moderate to severe symptomatic intracranial atherosclerotic stenosis patients (LDL-C>1.8mmol/L) without endovascular therapy.

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+Detailed description

sICASBLM aims to determine the effectiveness of conventional lipid management combined with PCSK9 inhibitors compared to conventional lipid management (atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg) in reducing the incidence of recurrent stroke in patients with moderate to severe symptomatic intracranial atherosclerotic stenosis (LDL-C>1.8mmol/L) without endovascular therapy.

+Arms and interventions

Arm	Type	Interventions	Description
Intervention group	Experimental	Drug: PCSK9 inhibitor	Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months
Control group	No intervention		Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg for 6-12 months

PCSK9 inhibitor (Drug), also known as intensive blood lipid lowing: The aim is to improve blood lipid management by using atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months

+Outcome measures

Primary outcomes

Recurrent stroke [6 months-12 months]: the recurrent rate of clinical stroke

Secondary outcomes

Intracranial arterial [6 months or 12 months]: Degree of change in intracranial arterial stenosis
Plaque changes [6 months or 12 months]: Plaque volume and load changes
Vascular remodeling index [6 months or 12 months]: Vascular remodeling index changes
Adverse events [6 months or 12 months]: The incidence of muscle related events, allergic reactions, injection site reactions, bleeding events and other adverse events was assessed

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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

+Locations (2)

Facility	City	Country	Status
Nanjing First Hospital, Nanjing Medical University	Nanjing, Jiangsu	China	Recruiting
Nanjing First Hospital	Nanjing, Jiangsu	China	Recruiting

+Publications

Results publication: Li Z, Sun C, Zhang Q, Ji L, Zhang Y, Li S, Gu M, Gao J, Huang Z, Wang M, Zhou J, Zhu L, Jiang T, Zhou Q, Deng Q. Impact of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor on Immune-Inflammatory Responses in the Acute Phase of Ischemic Stroke. J Inflamm Res. 2026 Apr 30;19:590179. doi: 10.2147/JIR.S590179. eCollection 2026. PMID 42089099
Results publication: Li Z, Liu X, Sun H, Jiang X, Zhang Y, Ji L, Zhang L, Wang M, Gu M, Li S, Zhang Y, Liu Y, Shi H, Jiang T, Mei Y, Zhu L, Zhou J, Deng Q. Predictors for recurrent ischemic stroke in patients with watershed infarct induced by intracranial artery stenosis. Clin Neurol Neurosurg. 2025 Jul;254:108897. doi: 10.1016/j.clineuro.2025.108897. Epub 2025 Apr 18. PMID 40288288