The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography: Single Center, Randomized, Open-label, Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- the change in fibrous cap thickness
研究概览
简要总结
the purpose of this study is to show that alirocumab with statin therapy have a s tronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration
详细描述
The investigators investigate to evaluate the efficacy of alirocumab for vulnerable plaque. The investigators enrolled the patient with standard statin therapy who were detected vulnerable plaque by optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin were categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group. The investigators compare these two group for outcomes.
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 have been had TCFA detected by OCT
- •Patients aged ≥20 years old at PCI
- •Patients who agree to be enrolled in the trial giving 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 breast-feeding women
- •Considered by the investigator as inappropriate for this study for any reason
研究组 & 干预措施
Alirocumab therapy group
start with alirocumab 75mg per 2weeks and rosuvastatin 10mg per day
干预措施: Alirocumab (Drug)
结局指标
主要结局
the change in fibrous cap thickness
时间窗: 9 month
the absolute change in minimum fibrous-cap thickness between baseline and 36-week follow-up
次要结局
- the change in macrophage grade(9 month)
- the change in minimum lumen area(9 month)
- the change in LDL-C(9 month)
- the change in HDL-C(9 month)
- the change in apolipoprotein B(9 month)
- the change in Lp(a)(9 month)
- the change in TNF-α(9 month)
- the change in MCP-1(9 month)
- the change in MMP-2(9 month)
- the change in ICAM-1(9 month)
- the change in total cholesterol(9 month)
- the change in hs-CRP(9 month)
- the change in IL-6(9 month)
- the change in free PCSK9(9 month)
- the change in lipid index(9 month)
- the change in lipid length,(9 month)
- the change in mean lipid arc(9 month)
- the number of thin-cap fibroatheroma(9 month)
- the change in IL-1β(9 month)
- the change in fibrous cap thickness(9 month)
- the change in max lipid arc(9 month)
- the change in non-HDL-C(9 month)
- the change in MMP-9(9 month)
- the change in VCAM-1(9 month)
研究者
Hiromasa Otake
Senior Lecturer
Kobe University