NCT07142265招募中不适用
Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 18
- 主要终点
- Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events registered within 12 months after inclisiran initiation in addition to basic therapy
研究概览
简要总结
Evaluation of clinical outcomes during 12 months after inclisiran initiation in patients after STEMI/non-STEMI in real-world settings in Russia. It is also planned to study the therapy effect on the lipid profile characteristics, its safety, the state of atherosclerotic plaques according to carotid ultrasound, the frequency of hospitalizations and the need for intensive follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of both genders
- •Myocardial Infarction diagnosis
- •Dyslipidemia diagnosis
- •The first injection of inclisiran no later than 14 ± 5 days after the STEMI/non-STEMI
- •LDL-C > 5 mmol/L (statin-naive patients) or LDL-C > 2.5 mmol/L (on the basis of statin MTD) at the time of hospitalization or no target LDL-C level (> 1.4 mmol/L or no LDL-C level decrease by 50% on statin MTD + ezetimibe)
- •Signed Informed Consent Form (ICF)
排除标准
- •Severe oncological and somatic diseases with system and organ failure*
- •Competing diseases that caused emergency hospitalization (pulmonary thromboembolism, aortic dissection)
- •History of therapy with PCSK9 inhibitors
- •Active inflammatory liver disease or the levels of AST, ALT > 3 times, or total bilirubin > 2 times higher than the upper limit of norm
- •Any other MACE in the anamnesis
研究组 & 干预措施
STEMI/Non-STEMI
Patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI
结局指标
主要结局
Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events registered within 12 months after inclisiran initiation in addition to basic therapy
时间窗: 12 months
Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events (cardiac death, nonfatal MI, nonfatal ischemic stroke, and hospitalization for unstable angina) registered within 12 months after the start of inclisiran therapy prescribed in addition to basic LLT
次要结局
- Change and absolute change in lipid profile parameters(Baseline, month 3, month 9, month 12)
- Change and absolute change in lipid profile parameters in patients subgroups(Baseline, month 3, month 9, month 12)
- Change in LDL-C level(Baseline, Day 28)
- The proportion of patients who maintain the target LDL-C level(Month 3, Month 12)
- The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L(Day 28 , Month 12)
- The proportion of patients with progression and regression/no changes in atherosclerotic plaque(Baseline, Month 12)
- Number (%) of patients who achieved the target LDL-C level of < 1.4 mmol/L and with change in the maximum plaque height (mm)(12 months)
- Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE)(Month 3, Month 9, Month 12)
- The number of patients who discontinued inclisiran therapy due to AEs(Month 3, Moth 9, Month 12)
- The number of patients re-hospitalized for CV events during the year(12 months)
- The number of patients re-hospitalized during the year for scheduled and unscheduled revascularization(12 months)
- Number of patients who sought emergency care after the baseline visit(12 months)
- The number of patients placed under dispensary observation(12 months)
- Number of days from the date of hospital discharge to place under dispensary observation(12 months)
研究者
研究点 (18)
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