Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Lipid index change between baseline and 9 month follow-up
研究概览
简要总结
The aim of this study is to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis by using optical coherence tomography, in comparison with standard statin therapy.
详细描述
The investigators investigate to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis. The investigators enrolled the patient who performed drug eluting stent implantation and detected in-stent neoatherosclerosis by follow up optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin the investigatorsre 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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The age at the time of consent acquisition is 20 years old or over.
- •OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent
- •lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed.
- •Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed.
- •Document consent has been obtained from the subject person to this research.
排除标准
- •Patients who have received treatment with PCSK 9 inhibitor in the past
- •Patients whose treatment was interrupted before follow-up catheterization during the observation period
- •Patients underwent LDL apheresis.
- •In the case that the researchers judges it as inappropriate as the object of this research.
研究组 & 干预措施
alirocumab therapy group
patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks
干预措施: Alirocumab (Drug)
结局指标
主要结局
Lipid index change between baseline and 9 month follow-up
时间窗: Baseline and 9 month follow-up
Lipid core arc was measured by every 0.2-mm interval throughout segments with neoatherosclerosis (NA) on optical coherence tomography (OCT) findings. The mean lipid core arc was calculated for each lesion. Then, the lipid index was calculated by multiplying the mean lipid core arc by the lipid core longitudinal length.
次要结局
- Macrophage grade change between baseline and 9 month follow-up(Baseline and 9 month follow-up)
研究者
Hiromasa Otake
Principal Investigator
Kobe University