NCT07704190尚未招募4 期
A Prospective, Randomized, Open-Label, Parallel-Controlled Study to Evaluate the Efficacy and Safety of Targeted Interleukin-17A (IL-17A) Inhibitor (Secukinumab) on Cardiovascular and Renal Endpoints in Patients With Cardiorenal Metabolic Syndrome Complicated With Atherosclerotic Cardiovascular Disease
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Time to First Occurrence of 3-point Major Adverse Cardiovascular Events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at screening.
- •Meet at least one metabolic abnormality:
- •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%;
- •Serum triglycerides ≥ 3.51 mmol/L;
- •Documented hypertension, metabolic syndrome, or diabetes mellitus.
- •Meet at least one diagnostic criterion for chronic kidney disease:
- •eGFR ≥15 and <60 mL/min/1.73 m² (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine equation);
- •UACR ≥ 200 mg/g with eGFR ≥ 60 mL/min/1.73 m² and documented albuminuria.
- •Have documented atherosclerotic cardiovascular disease (at least one):
- •Coronary heart disease: history of myocardial infarction, prior coronary revascularization, or ≥50% major epicardial coronary artery stenosis confirmed by cardiac catheterization or coronary coronary computed tomography angiography (CTA);
- •Cerebrovascular disease: prior atherosclerotic stroke, prior carotid revascularization, or ≥50% carotid artery stenosis confirmed by imaging;
- •Symptomatic peripheral artery disease.
- •Able and willing to provide written informed consent.
排除标准
- •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.
- •Current use of systemic immunosuppressive agents (glucocorticoids, small-molecule immunosuppressants, biologic DMARDs, anti-tumor drugs).
- •Long-term intermittent hemodialysis or peritoneal dialysis.
- •History or confirmed evidence of active tuberculosis.
- •History of inflammatory bowel disease.
- •Active malignancy or carcinoma in situ within the past 5 years.
- •Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
- •Chronic heart failure classified as New York Heart Association (NYHA) Class IV.
- •History of bone marrow or solid organ transplantation, or planned organ transplantation during the study.
- •Known or suspected allergy to secukinumab or related excipients.
- •Pregnant, lactating females, or females of childbearing potential without adequate effective contraception.
- •Absolute neutrophil count <2 ×10⁹/L or platelet count <120 ×10⁹/L, or alanine aminotransferase (ALT) / aspartate aminotransferase (AST) >2.5 × upper limit of normal.
- •HbA1c ≥10% (≥86 mmol/mol).
- •Any disease condition that may endanger subject safety or impair protocol compliance per investigator judgment.
- •Subjects with inadequate standard therapy judged by investigators.
结局指标
主要结局
Time to First Occurrence of 3-point Major Adverse Cardiovascular Events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
时间窗: From randomization up to 2 years
次要结局
- Changes in UACR(Baseline, Month 6, Month 24)
- Changes in eGFR(Baseline, Month 6, Month 24)
- Annual slope of eGFR(Baseline, Month 6, Month 24)
- Changes in high-sensitivity C-reactive protein (hs-CRP)(Baseline, Month 6, Month 24)
- Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP)(Baseline, Month 6, Month 24)
- Number of new-onset atrial fibrillation events(From randomization up to 2 years)
- Changes in hemoglobin levels(Baseline, Month 6, Month 24)
- Total number of heart failure hospitalizations, urgent heart failure visits or cardiovascular death(From randomization up to 2 years)
- All-cause mortality(From randomization up to 2 years)
- Changes in carotid artery stenosis degree(Baseline, Month 6, Month 24)
- Changes in carotid artery plaque size(Baseline, Month 6, Month 24)
- Time to composite chronic kidney disease endpoint (sustained eGFR decline ≥30% or kidney failure)(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)(From randomization up to 2 years)
- Time to first extended MACE composite endpoint(From randomization up to 2 years)
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