This is a prospective, randomized, open-label, parallel-controlled clinical trial to evaluate the efficacy and safety of targeted IL-17A inhibition with secukinumab on cardiovascular and renal endpoints in 100 patients with cardiorenal metabolic syndrome and atherosclerotic cardiovascular disease (ASCVD). Eligible subjects will be randomized 1:1 to receive either secukinumab 75 mg subcutaneous injection every 4 weeks for a total of 12 weeks plus standard guideline-directed medical therapy, or standard medical therapy alone. The primary endpoint is the time to first occurrence of 3-point major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) over a 2-year follow-up period. Key indicators include estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR) for renal outcome assessment.
Age ≥ 18 years at screening.
Body mass index ≥ 23 kg/m²;
Waist circumference ≥ 80 cm (female) or ≥ 90 cm (male);
Fasting glucose 100-124 mg/dL (5.6-6.9 mmol/L) or glycated hemoglobin (HbA1c) 5.7-6.4%;
Clinical evidence or suspected active infection judged by investigators.
History of myocardial infarction, stroke, transient ischemic attack, or hospitalization for unstable angina within 60 days prior to randomization.
Planned coronary, carotid, or peripheral artery revascularization at randomization.
Major cardiac surgery, non-cardiac major surgery, or major endoscopy within 60 days before randomization, or planned major surgery during the study period.
Parallel
Secukinumab (75 mg)
Biological/Vaccine75 mg, subcutaneous injection, once every 4 weeks for a total of 12 weeks
Standard Medical Therapy
Other interventionStandard guideline-directed cardiovascular and renal protective therapy per clinical practice guidelines
Time to First Occurrence of 3-point Major Adverse Cardiovascular Events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
Time to first extended MACE composite endpoint
Total number of heart failure hospitalizations, urgent heart failure visits or cardiovascular death
All-cause mortality
Changes in carotid artery stenosis degree
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