To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy (POLARIS)
Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Hiromasa Otake, M.D., Ph.D
- 电话号码:+81-78-382-5111
- 邮箱:hotake@med.kobe-u.ac.jp
研究联系人备份
- 姓名:Yoichiro Sugizaki, M.D.
- 电话号码:+81-78-382-5111
- 邮箱:you0724@med.kobe-u.ac.jp
学习地点
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Hyogo
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Kobe、Hyogo、日本、650-0017
- 招聘中
- Kobe University Graduate School of Medicine, Department of Cardiology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients with stent implantation who were performed coronary angiography and optical coherence tomography (OCT) follow-up of the coronary arteries were candidate.
These patients were implanted drug elutingstent including sirolimus-eluting stents (Cypher, Cordis, Miami Lakes, FL, USA), paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, MA, USA), or everolimus-eluting stents (XIENCE V, Abbott Vascular, Santa Clara, CA, USA). The investigators assessed their OCT examination at the follow-up OCT time and patients who were detected NA on OCT findings were eligible for the presence study.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
alirocumab therapy group
patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks
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the administration of Alirocumab at least 75mg every 2 weeks
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standard statin therapy group
patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Lipid index change between baseline and 9 month follow-up
大体时间:Baseline and 9 month follow-up
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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.
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Baseline and 9 month follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Macrophage grade change between baseline and 9 month follow-up
大体时间:Baseline and 9 month follow-up
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Macrophage arc were measured on OCT images with NA every 0.2-mm intervals and divided 4 groups as follows: grade 0, no mac¬rophage; grade 1, localized macrophage accumulation (<30°); grade 2, clus¬tered accumulation ≥30° and <90°; grade 3, clus¬tered accumulation ≥90° and <270°; and grade 4, clustered accumulation ≥270° and <360° .
Macrophage grade was evaluated as summation of 0 to 4 grades across all cross section in NA.
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Baseline and 9 month follow-up
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合作者和调查者
调查人员
- 学习椅:Hiromasa Otake, M.D., Ph.D、Kobe University Graduate School of Medicine
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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