Effect of Early Initiation of Evolocumab and Combination Lipid-lowering Agent on Lipid Profiles Changes in Patients With Acute Coronary Syndrome Undergoing percuTAneous coronaRy Intervention: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Percent change in LDL level (%)
研究概览
简要总结
Investigators aimed to evaluate efficacy and safety of early Initiation of evolocumab and combination lipid-lowering agent (statin + Ezetimibe) on lipid profiles changes in patients with ACS undergoing PCI
详细描述
Recently, studies have reported that strong LDL cholesterol lowering through PCSK9 inhibitors early in patients with acute myocardial infarction under coronary intervention results in plaque stability as well as plaque regression, which is the cause of arteriosclerosis in the coronary artery. However, the LDL cholesterol reduction effect on statin is different from that of Westerners and Asians, and studies on the LDL cholesterol reduction effect of Koreans on the early use of PCSK9 inhibitors are insufficient. Therefore, we would like to study the effect of reducing LDL cholesterol by administering Evolocumab early after the procedure in patients who underwent percutaneous coronary stent insertion for acute coronary syndrome in the real world.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 19 years old
- •Patients who agreed to the research protocol and clinical follow-up survey plan, decided to participate in this study voluntarily, and gave written consent to the informed consent form.
- •Patients who underwent percutaneous coronary stenting for acute coronary syndrome
排除标准
- •Patients who have previously taken statins,
- •Patients with active liver disease or patients with three times or more increase in AST or ALT
- •If you have an allergic or hypersensitivity reaction to Evorucumab, statin, or Ezetimib,
- •Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
- •The remaining life expectancy is expected to be less than a year.
- •Subjects who visited the hospital due to psychogenic shock and are expected to be less likely to survive by medical judgment
- •Subjects participating in a randomized clinical trial of medical devices/pharmaceuticals
研究组 & 干预措施
Evolocumab treatment group
The experimental group will receive Rosuvastatin 5 mg, Ezetimibe 10 mg, and evolocumab by subcutaneous injection. Evolocuumab will be administered at a dose of 140 mg once during the study period.
干预措施: Evolocumab 140 MG/ML (Drug)
Evolocumab treatment group
The experimental group will receive Rosuvastatin 5 mg, Ezetimibe 10 mg, and evolocumab by subcutaneous injection. Evolocuumab will be administered at a dose of 140 mg once during the study period.
干预措施: Rosuvastatin 5mg (Drug)
Evolocumab treatment group
The experimental group will receive Rosuvastatin 5 mg, Ezetimibe 10 mg, and evolocumab by subcutaneous injection. Evolocuumab will be administered at a dose of 140 mg once during the study period.
干预措施: Ezetimibe 10mg (Drug)
Group not receiving evolocumab
The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg.
干预措施: Rosuvastatin 5mg (Drug)
Group not receiving evolocumab
The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg.
干预措施: Ezetimibe 10mg (Drug)
结局指标
主要结局
Percent change in LDL level (%)
时间窗: Baseline, 2 weeks later
Difference in LDL level change between baseline and 2 weeks later in the test group and control group
次要结局
- Percent change in LDL level (%)(baseline, 2 weeks later 4 weeks later)
- Differences in LDL level change (mg/dL)(baseline, 2 weeks later 4 weeks later)
- Presence or absence of side effects(baseline, 2 weeks later 4 weeks later)
- Liver function test including Aspartate aminotransferase(AST)/alanine aminotransferase(ALT) (IU/L) level(baseline, 2 weeks later 4 weeks later)
- Creatine kinase(CK) (IU/L)(baseline, 2 weeks later 4 weeks later)
- C-Reactive Protein(CRP) (mg/L)(baseline, 2 weeks later 4 weeks later)
- Lipoprotein(a) (nmol/L)(baseline, 2 weeks later)
- HbA1c(%) level(baseline, 4 weeks later)
- Cognitive function analysis(2 weeks later)
研究者
Yongcheol Kim
Clinical Associate Professor
Yonsei University