Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- maxLCBI (4mm)
研究概览
简要总结
The purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the coronary artery 9 months after administration by addition administration of Alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have CAD and received PCI. Also, change of plaque properties is compared with baseline and evaluated. This study is a single-center, randomized, open-label study, using alirocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary There is a possibility that it can contribute to prevention.
详细描述
The investigators investigate the change in the maxLCBI (4 mm) value calculated by NIRS-IVUS at the time of PCI and at the treatment evaluation after 9 months compared with the group of Alirocumab(Alirocumab75mg/2week+losuvastatin10mg/daily) and standard treatment (losuvastatin10mg/daily alone). And also the investigators evaluate LCBI(lesion), Angle of a lipid core, EEM CSA, Lumen CSA, Minimum lumen diameter, Plaque burden, Lesion length by NIRS-IVUS.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent PCI for ACS or stable coronary heart disease
- •Patients with LDL-C ≥70 mg/dL under daily 10mg rosuvastatin
- •Patients who remained 25-75% stenosis with coronary angiography
- •Patients who obtained analyzable images and calculated maxLCBI (4 mm) with NIRS-IVUS
- •Patients aged ≥20 years old at PCI
- •Patients who agree to be enrolled in the trial give signed written informed consent
排除标准
- •Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody
- •Patients had uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) between the time of PCI and randomization visit
- •Known hypersensitivity to alirocumab or rosuvastatin
- •All contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments
- •Known history of hemorrhagic stroke
- •Currently under treatment for cancer
- •Patients on lipoprotein apheresis
- •Patients with severe liver or renal dysfunction
- •Pregnant or breastfeeding women
- •Patients recognized as inadequate by attending physician
研究组 & 干预措施
Intensive therapy group
Alirocumab group is Alirocumab75mg/2week plus Rosuvastatin10mg/daily.
干预措施: Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily (Drug)
Standard therapy group
The standard therapy group is Rosuvastatin10mg/daily alone.
干预措施: Rosuvastatin calcium10mg (Drug)
结局指标
主要结局
maxLCBI (4mm)
时间窗: baseline and 9 months
次要结局
- change amount of LCBI(lesion)(baseline and 9 months)
- change amount of Angle of lipid core(baseline and 9 months)
- change amount of LDL-Cholesterol level(baseline and 9 months)
研究者
Hiromasa Otake
senior lecturer
Kobe University