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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
75 mg, subcutaneous injection, once every 4 weeks for a total of 12 weeks
Standard 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 frame: From randomization up to 2 years
Time to first extended MACE composite endpoint
Time frame: From randomization up to 2 years
Total number of heart failure hospitalizations, urgent heart failure visits or cardiovascular death
Time frame: From randomization up to 2 years
All-cause mortality
Time frame: From randomization up to 2 years
Changes in carotid artery stenosis degree
Time frame: Baseline, Month 6, Month 24
Changes in carotid artery plaque size
Time frame: Baseline, Month 6, Month 24
Time to composite chronic kidney disease endpoint (sustained eGFR decline ≥30% or kidney failure)
Time frame: From randomization up to 2 years
Incidence of kidney failure (death due to renal failure, sustained eGFR <15 mL/min/1.73 m², or long-term renal replacement therapy)
Time frame: From randomization up to 2 years
Changes in UACR
Time frame: Baseline, Month 6, Month 24
Changes in eGFR
Time frame: Baseline, Month 6, Month 24
Annual slope of eGFR
Time frame: Baseline, Month 6, Month 24
Changes in high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline, Month 6, Month 24
Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: Baseline, Month 6, Month 24
Number of new-onset atrial fibrillation events
Time frame: From randomization up to 2 years
Changes in hemoglobin levels
Time frame: Baseline, Month 6, Month 24
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