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To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy (POLARIS)

2018年5月28日 更新者:Hiromasa Otake、Kobe University

Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography

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.

研究概览

地位

招聘中

干预/治疗

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

观察性的

注册 (预期的)

31

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Hyogo
      • Kobe、Hyogo、日本、650-0017
        • 招聘中
        • Kobe University Graduate School of Medicine, Department of Cardiology

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

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:

  1. The age at the time of consent acquisition is 20 years old or over.
  2. OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent
  3. lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed.
  4. Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed.
  5. Document consent has been obtained from the subject person to this research.

Exclusion Criteria:

  1. Patients who have received treatment with PCSK 9 inhibitor in the past
  2. Patients whose treatment was interrupted before follow-up catheterization during the observation period
  3. Patients underwent LDL apheresis.
  4. In the case that the researchers judges it as inappropriate as the object of this research.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
the administration of Alirocumab at least 75mg every 2 weeks
standard statin therapy group
patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor

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
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.
Baseline and 9 month follow-up

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
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.
Baseline and 9 month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年12月18日

初级完成 (预期的)

2020年12月1日

研究完成 (预期的)

2025年12月1日

研究注册日期

首次提交

2018年5月11日

首先提交符合 QC 标准的

2018年5月22日

首次发布 (实际的)

2018年5月23日

研究记录更新

最后更新发布 (实际的)

2018年5月30日

上次提交的符合 QC 标准的更新

2018年5月28日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

Alirocumab的临床试验

3
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