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

Intracranial Artery Stenosis Clinical Trial

— sICASBLM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397405
• Other study ID #: sICASBLM
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: June 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Junshan Zhou
• Phone: 8602587726218
• Email: zhjsh333[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intracranial Artery Stenosis

Intervention

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

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent stroke	the recurrent rate of clinical stroke	6 months-12 months
Secondary	Intracranial arterial	Degree of change in intracranial arterial stenosis	6 months or 12 months
Secondary	Plaque changes	Plaque volume and load changes	6 months or 12 months
Secondary	Vascular remodeling index	Vascular remodeling index changes	6 months or 12 months
Secondary	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