Cardiovascular disease
Conditions
Interventions
Experimental Group:Experimental Group: Original treatment + Recaticimab 300mg, Q8W (Note: Original treatment refers to maintaining the patient’s existing treatment regim
Control Group:Control Group: Basic lipid-lowering treatment
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years and = 10%; 3. Coronary computed tomography angiography (CCTA) shows coronary artery stenosis degree > 50% with non-obstructive plaque lesions; 4. Patients who meet either of the following lipid-related conditions:Have received statin monotherapy, or statin combined with cholesterol absorption inhibitor therapy for more than 1 month, with low-density lipoprotein cholesterol (LDL-C) >= 1.8 mmol/L Have not received any lipid-lowering therapy, with LDL-C >= 1.8 mmol/L And all such patients must have fasting triglycerides (TG) <= 5.6 mmol/L; 5. Voluntarily sign the informed consent form before the start of trial-related activities, be able to understand the procedures and methods of the trial, and be willing to comply with the clinical trial protocol strictly to complete the trial.
Exclusion criteria
Exclusion criteria: 1. Known allergy to recaticimab; 2. Active liver disease or severe hepatic insufficiency, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 times the ULN; 3. Patients who have received PCSK9 inhibitors within the past 3 months or been administered Inclisiran ; 4. Patients diagnosed with malignant tumors; 5. Estimated life expectancy less than 2 year; 6. Class III or Class IV angina pectorisNew York Heart Association (NYHA) functional class IV heart failure or left ventricular ejection fraction (LVEF) < 30% Uncontrolled hypertension, defined as systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg; 7. Valvular heart disease requiring surgical intervention within 12 months ; 8. History of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months;Acute cardiovascular events (e.g., myocardial infarction, stroke) within the past 6 months; 9. Known genetic diseases influencing atherosclerotic progression (e.g. ,familial hypercholesterolemia type 1, inborn metabolic disorders) ; 10. Factors that may affect the quality and safety of coronary CTA (such as atrial fibrillation, significant ventricular arrhythmias (e.g., symptomatic ventricular tachycardia, second - degree type II or third - degree heart block without a pacemaker), poor patient cooperation, renal insufficiency with eGFR < 45 ml/min/1.73m², women who are pregnant or plan to become pregnant within 1 year), or low - quality data obtained from CTA; 11. Participation in another interventional clinical trial within the past 3 months; 12. Any other condition deemed unsuitable for trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The NCPV score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The level of the perivascular adipose tissue attenuation index (pFAI);non-HDL-C;The plaque area stenosis rate;LDL - C;Lipoprotein(a), Lp(a);Diameter Stenosis Rate;Adverse events (AEs);Incidence of MACE (Major Adverse Cardiovascular Events), defined as cardiovascular death, myocardial infarction, stroke, and target vessel revascularization.;Quality of life;Apolipoprotein B; | — |
Countries
China
Contacts
Public ContactJianan Wang
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed