Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (EVALUATE-STEMI Trial): a Prospective, Multicenter, Open-label, Adjudicator-blinded, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 119
- 试验地点
- 6
- 主要终点
- Change in left ventricular ejection fraction (LVEF)
研究概览
简要总结
For patients with anterior ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), whether early application of proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors to rapidly reduce low-density lipoprotein cholesterol (LDL-C) before PCI could effectively inhibit left ventricular remodeling has been rarely reported. The aim of this study was to investigate the effect of early application of PCSK9 inhibitors Evolocumab to rapidly reduce LDL-C levels before primary PCI treatment on left ventricular remodeling in STEMI patients.
Eligible patients were randomly randomized 1:1:1 to one of the following three groups immediately after enrollment: (1) Intensive statin group: rosuvastatin 20 mg per day, in addition to usual therapy; (2) Combined intensive statin and PCSK9 inhibitor group: rosuvastatin 20 mg per day and subcutaneous injection of evolocumab 140 mg twice a month, for at least 3 months, and preferably 6 months; (3) PCSK9 inhibitor alone group: subcutaneous injection of evolocumab 140 mg, twice a month for at least 3 months and preferably 6 months.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Persistent chest pain or chest discomfort
- •Onset within 12 hours
- •ST-segment elevation ≥0.1 millivolt in two adjacent precordial leads, or a new-onset left bundle branch block with dynamic changes
- •Primary PCI is planned
排除标准
- •Contraindications to Statins or PCSK9 inhibitors
- •Prior intravenous thrombolytic therapy
- •Prior use of Statins, PCSK9 inhibitors or Ezetimibe
- •Cardiogenic shock
- •Acute heart failure or pulmonary edema
- •Prior chronic heart failure
- •Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate <30ml/min/1.73m2, or on dialysis)
- •Prolonged (> 20 minutes) cardiopulmonary resuscitation
- •Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall)
- •Malignant arrhythmias that are difficult to control with drugs
- •Severe chronic obstructive pulmonary disease or respiratory failure
- •Severe infection
- •Neurological disorders
- •Bleeding history of cerebrovascular, gastrointestinal, respiratory, urinary or other organs within the last month
- •Active bleeding or bleeding diatheses
- •Use of anticoagulants
- •Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year
- •Pregnant or lactating women
研究组 & 干预措施
Intensive statin group
Rosuvastatin, 20 mg per day after randomization
干预措施: Rosuvastatin 20 mg (Drug)
Combined intensive statin and PCSK9 inhibitor group
Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization
干预措施: Rosuvastatin 20 mg (Drug)
Combined intensive statin and PCSK9 inhibitor group
Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization
干预措施: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA] (Drug)
PCSK9 inhibitor alone group
Evolocumab, 140 mg twice a month after randomization
干预措施: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA] (Drug)
结局指标
主要结局
Change in left ventricular ejection fraction (LVEF)
时间窗: Baseline and 12 weeks
Echocardiography Core Laboratory, blinded analysis
次要结局
- Change in left ventricular end diastolic/systolic diameter(Baseline and 12 weeks)
- Change in left ventricular end diastolic/systolic volume(Baseline and 12 weeks)
- A composite of cardiovascular death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure(12 weeks, 52 weeks)
- Proportion of LDL-C < 1.4 mmol/L(One week, 12 weeks)
- Thrombolysis in Myocardial Infarction (TIMI) flow grade(TIMI flow in culprit coronary artery at first coronary angiography, and immediately after primary PCI within 12 hours of onset)
- Level of troponin(24 hours, 48 hours, and at hospital discharge, an average of 10 days after randomization)
- Number of patients with adverse events and serious adverse events(At hospital discharge, an average of 10 days after randomization)
研究者
Chuanyu Gao
Vice President, Chief of Cardiology Department
Henan Institute of Cardiovascular Epidemiology