A Single-center, Randomized, Parallel-group, Open-label Pilot Study to Evaluate the Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patients Who Underwent Percutaneous Coronary Intervention for the Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of 1-year lipid core burden index
研究概览
简要总结
This study aimed to investigate the impact of intensive cholesterol-lowering therapy (including evolocumab), drug treatment for high-risk plaques (Vulnerable plaques) with a high probability of developing acute coronary syndrome. The purpose of this study is to determine the effect of the change in the Lipid core burden index and compare the rate of cardiac events over 12 months following cholesterol therapy.
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 agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information
- •Patients who underwent NIRS-IVUS guided coronary stent surgery for acute coronary syndrome
- •Patients who did not meet the LDL-Cholesterol level (<70mg/dL) even after receiving the maximum dose of combined cholesterol therapy for 2 months
排除标准
- •Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel And contrast agents (however, even a subject who is hypersensitive to contrast agents can register if they can be controlled by steroids and pheniramine, except for known anaphylaxis.)
- •Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
- •Subjects who plan to have surgery to stop antiplatelet drugs within 12 months from registration
- •Those whose surviving life is expected to be less than 1 year
- •Subjects who visited the hospital due to psychogenic shock and are predicted to have low survival probability based on medical judgment
- •Subjects participating in a randomized study on cholesterol therapy
研究组 & 干预措施
Statin+Ezetimibe+Evolocumab
Drug: Statin + Ezetimibe (combined cholesterol therapy) and Drug: Evolocumab
干预措施: NIRS IVUS (Device)
Statin+Ezetimibe
Drug: Statin + Ezetimibe (combined cholesterol therapy)
干预措施: Evolocumab (Drug)
Statin+Ezetimibe
Drug: Statin + Ezetimibe (combined cholesterol therapy)
干预措施: NIRS IVUS (Device)
Statin+Ezetimibe+Evolocumab
Drug: Statin + Ezetimibe (combined cholesterol therapy) and Drug: Evolocumab
干预措施: Evolocumab (Drug)
结局指标
主要结局
Change of 1-year lipid core burden index
时间窗: 1 year
次要结局
- patient-oriented composite end point(1 year)
- Percentage of myocardial infarction(1 year)
- Percentage of revascularization(1 year)
- Percentage of All cause mortality(1 year)
- Percentage of cardiac death(1 year)
- Rate of usage of cholesterol lowering agents (2 month)(1 year)
- Rate of usage of cholesterol lowering agents (12 month)(1 year)
研究者
Jung-Joon Cha
Assistant Professor
Korea University Anam Hospital