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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Artery Stenosis
• Intervention / Treatment: Drug: PCSK9 inhibitor

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junshan Zhou; Phone Number: 8602587726218; Email: zhjsh333@126.com
• Study Contact Backup: Name: Qiwen Deng; Phone Number: 8602587726218; Email: qiw_deng@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital, Nanjing Medical University
      • Contact: Junshan Zhou, M.D.; Phone Number: +86025-87726218; Email: zhjsh333@126.com
      • Contact: Qiwen Deng, M.D.; Phone Number: +86025-87726218; Email: qiw_deng@163.com
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months	Drug: PCSK9 inhibitor; 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; Other Names: intensive blood lipid lowing
No Intervention: Control group; Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg for 6-12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent stroke	the recurrent rate of clinical stroke	6 months-12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: stroke; symptomatic intracranial atherosclerotic stenosis; blood lipid management; PCSK9 inhibitors
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Antimetabolites; Serine Proteinase Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; PCSK9 Inhibitors
• Other Study ID Numbers: sICASBLM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No