Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction: A Single-center，Randomized,Open-label Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Average percent change from baseline in LDL-C levels to discharge and day 30
研究概览
简要总结
Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early ischemic events, remains high. Current research suggests that low-density lipoprotein cholesterol (LDL-C) levels not meeting guideline-recommended levels and inflammation are closely related to early recurrent ischemic events. Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, rapidly and effectively reduces LDL-C levels and suppresses inflammation. Long-term use in patients with acute coronary syndromes can reverse atherosclerosis and improve prognosis. However, data on its use in STEMI patients are limited, particularly regarding the cardioprotective effects of preoperative administration of 420mg evolocumab subcutaneous injection. This study aims to evaluate the effects of administering evolocumab 420mg before emergency PCI on lipid profiles, inflammatory markers, myocardial injury, and short-term prognosis in STEMI patients through a single-center, randomized, open-label study. It aims to provide theoretical evidence for further reducing the risk of recurrent cardiovascular events in STEMI and identifying more optimized treatment strategies.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients are selected from the Cardiology Department of Beijing Luhe Hospital and have undergone direct PCI treatment for STEMI.
- •STEMI patients must meet the following criteria:
- •Chest pain duration ≥ 30 minutes, with ST-segment elevation ≥ 0.1 mV in adjacent two leads on the electrocardiogram.
- •Onset within 24 hours.
- •Aged between 18 and 80 years.
- •Signed informed consent form.
排除标准
- •Hemodynamically unstable or Killip grade ≥
- •Severe renal insufficiency: Glomerular filtration rate < 30 ml/min/1.73m^
- •Active liver disease or liver dysfunction: AST or ALT levels > 3 times the upper limit of normal.
- •Known allergy to any drug used in the study.
- •Previous or planned use of PCSK9 inhibitors.
- •Suspected stress cardiomyopathy or acute pericarditis.
- •Malignant tumors requiring treatment or other severe systemic diseases.
- •Pregnancy or breastfeeding
研究组 & 干预措施
Treatment arm: standard post-treatment for STEMI and Evolocumab
The intervention group will receive a preoperative subcutaneous injection of Evolocumab (420mg) and standard post-treatment for STEMI
干预措施: evolocumab (Drug)
Treatment arm: standard post-treatment for STEMI and Evolocumab
The intervention group will receive a preoperative subcutaneous injection of Evolocumab (420mg) and standard post-treatment for STEMI
干预措施: standard post-treatment for STEMI (Procedure)
Control arm: standard post-treatment for STEMI
Standard post-treatment for STEMI
干预措施: standard post-treatment for STEMI (Procedure)
结局指标
主要结局
Average percent change from baseline in LDL-C levels to discharge and day 30
时间窗: 30 days
次要结局
- Average percent change from baseline in MMP-9, CSF-1, IL-18R1 to discharge and day 30(30 days)
- Number of cardiovascular events to day 30(30 days)
- Average percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein A and apolipoprotein B to discharge and day 30(30 days)
研究者
Jincheng Guo
Clinical Professor
Beijing Luhe Hospital