Effect of Evolocumab on Non-culprit Coronary Lesions in Patients With Multivessel Disease Following Acute Myocardial Infarction: A Target Trial Emulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,862
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
The goal of this Target Trial Emulation (TTE) study is to evaluate the effect of evolocumab on clinical prognosis in patients with multivessel disease (MVD) following acute myocardial infarction (AMI) who have deferred non-culprit vessel. The main question it aims to answer is:
Does evolocumab lower risks of major adverse cardiovascular events (MACE) in patients with deferred non-culprit vessel after AMI?
详细描述
This study aims to investigate the potential prognostic benefits of evolocumab in patients with MVD after AMI at 2-year follow-up. The primary endpoint is MACE, defined as a composite of cardiac death, myocardial infarction, stroke, angina-driven coronary revascularization, and rehospitalization for heart failure. This is a multicentre, cohort-based TTE study and the target RCT is the FOURIER trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •Acute myocardial infarction diagnosed at hospital admission;
- •Multivessel coronary artery disease diagnosed at primary invasive coronary angiography;
- •Culprit vessel successfully revascularized;
- •At lease 1 non-culprit vessel with ≥50% stenosis and deferred at the opinion of the operator, and no staged revascularization within 6 months.
排除标准
- •Cardiac shock, hemodynamically unstable, or severe heart failure (Killip IV)
- •Any cardiac surgery within 6 weeks prior to screening;
- •Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m^2 at screening;
- •Contraindication or allergy to iodinated contrast agent;
- •Malignancy except non-melanoma skin cancers, cervical, or breast ductal carcinoma in situ within the last 5 years;
- •Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed in short term.
研究组 & 干预措施
TTE cohort
The TTE cohort is the finally anlyzed population. The participates are enrolled upon meeting the inclusion/exclusion criteria.
干预措施: Evolocumab (Drug)
TTE cohort
The TTE cohort is the finally anlyzed population. The participates are enrolled upon meeting the inclusion/exclusion criteria.
干预措施: Lipid Lowering Medication (Drug)
结局指标
主要结局
MACE
时间窗: 2 years
A composite of cardiac death, myocardial infarction, and rehospitalization for heart failure.
次要结局
- Death(2 years)
- Myocardial infarction(2 years)
- Rehospitalization for heart failure(2 years)