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

Not Applicable

Recruiting

• Conditions: Intracranial Artery Stenosis
• Interventions: Drug: PCSK9 inhibitor

• Registration Number: NCT05397405
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

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.

Study Timeline

• Study Start: 2022-05-23
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-05-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	PCSK9 inhibitor	Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months

Primary Outcome Measures

Name	Time	Method
Recurrent stroke	6 months-12 months	the recurrent rate of clinical stroke

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China

Nanjing First Hospital, Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China