Effects of Acute, Rapid Lowering of Low Density Lipoprotein Cholesterol With Alirocumab in Patients With ST Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Percent change in direct LDL cholesterol
研究概览
简要总结
A randomized, double-blind, placebo controlled parallel group clinical trial evaluating the effects of acute treatment with a PCSK9 inhibitor (alirocumab) versus placebo on low-density lipoprotein (LDL) in 100 high-risk patients presenting with STEMI and referred for primary PCI.
The objective is to determine the effect of acute, rapid lowering of LDL cholesterol with alirocumab added to high dose statin therapy in patients with STEMI undergoing primary PCI. The hypothesis is that, in patients with STEMI undergoing primary PCI, rapid lowering of LDL cholesterol with a PCSK9 Inhibitor (alirocumab) initiated in the acute setting pre-PCI, will favourably affect LDL cholesterol concentrations compared with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients presenting with STEMI defined as both of the following: a) Symptoms of myocardial ischemia lasting for ≥ 30 minutes, and b) Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads.
- •Referred for primary PCI for presenting symptoms.
- •Randomized within 12 hours of symptom onset and prior to diagnostic angiography.
排除标准
- •Age ≤18 years.
- •Pregnancy or breastfeeding.
- •Current or planned treatment with a PCSK9 inhibitor.
- •Allergy or contra-indication to a PCSK9 inhibitor.
- •Killip class ≥
- •Known Creatinine clearance <30mL/min.
- •Suspected takotsubo / stress-induced cardiomyopathy or acute pericarditis.
- •Any other medical, geographic, or social factor making study participation impractical or precluding follow-up.
研究组 & 干预措施
Alirocumab
干预措施: Alirocumab (Drug)
Sham Control
干预措施: Sham Control (Other)
结局指标
主要结局
Percent change in direct LDL cholesterol
时间窗: 6 weeks
次要结局
- Percent change in Apo B(6 weeks)