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临床试验/NCT06338293
NCT06338293招募中4 期

Using OFR Software to Observe the Effects of Inclisiran Combined with Statins on the Morphology and Vascular Function of Coronary Vulnerable Plaques

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
40
试验地点
1
主要终点
The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%)

研究概览

简要总结

Effects of inclisiran + statins vs. statins on the morphology and vascular function of coronary vulnerable plaques, in order to provide a better treatment and more detailed imaging basis for the treatment of coronary vulnerable plaques.

详细描述

The identification and treatment of vulnerable coronary plaques is still the focus of coronary heart disease research in recent several years. There are many methods to identify vulnerable plaque, such as NIRS, IVUS, OCT, but these methods have their own advantages and disadvantages, and they can't give the characteristics of diseased plaque completely and clearly. Therefore, if you want to better identify, track and treat vulnerable plaques, you need the comprehensive judgment of multi-modal detection methods, such as the comprehensive data of NIRS, IVUS, OCT, but in this case, there will be more and more invasive operations for patients, and the operation cost is high and time-consuming. OFR analysis software can quickly analyze the morphological and functional parameters of diseased vascular plaques based on OCT data, overcome the shortcomings of poor penetration of OCT and inability to observe the overall lesion contour, and can immediately give the morphological and functional parameters of diseased plaques, combining the data results of OCT, IVUS and FFR multimodal detection methods.

Statins have the effect of inducing regression and transforming coronary plaques into stability, but there are also some problems in the process of statin treatment. For example, for some patients with coronary heart disease, even the maximum tolerated dose of statins can not achieve the target goal of LDL-Cl; The side effects of statins, such as liver damage, muscle pain and blood sugar fluctuation, reduce the compliance of some patients. In recent years, the lipid-lowering effect of non-statins and the effect of stabilizing and reversing plaques have also attracted much attention, especially PCSK9 monoclonal antibody, such as, GLAGOV study, HUYGENS study, ALTAIR study and PACMAN-AMI study, compared with statins, they can reduce the plaques volume and stabilize the plaques morphology.

Inclisiran is the first siRNA drug in cardiovascular field. As a new generation of drugs acting on PCSK9, the current clinical research (ORION research series 1, 3, 8, 9, 10, 11) shows good lipid-lowering efficacy and safety tolerance. On the basis of statin therapy, LDL-C46%-55% is further reduced, which is more durable than monoclonal antibody, and the drug effect can last for half a year once used, and it has good safety and tolerance (except for the slight reaction of injection, there are almost no other side effects). So far, the research of Inclisiran mainly focuses on the safety and efficacy of lipid-lowering and the observation of clinical events, and the research on vulnerable plaque is very scarce. In this study, OFR analysis software will be used to observe whether Inclisiran combined with statin is superior to statin standard treatment on the vulnerable plaques, and it is expected to provide more superior clinical treatment scheme and more accurate imaging basis for identifying and treating vulnerable coronary plaques.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Inclisiran+rosuvastatin group

Experimental

Inclisiran sodium+rosuvastatin 20mg group: Rosuvastatin was given 20mg daily for one year, and Inclisiran was given three times in total. After the first injection, 284mg(1.5ml solution) was injected subcutaneously, the second injection was 3 months after the first injection, and the third injection was in the ninth month.

干预措施: Inclisiran sodium (Drug)

Inclisiran+rosuvastatin group

Experimental

Inclisiran sodium+rosuvastatin 20mg group: Rosuvastatin was given 20mg daily for one year, and Inclisiran was given three times in total. After the first injection, 284mg(1.5ml solution) was injected subcutaneously, the second injection was 3 months after the first injection, and the third injection was in the ninth month.

干预措施: Rosuvastatin (Drug)

Rosuvastatin group

Placebo Comparator

Rosuvastatin group: Rosuvastatin 20mg daily for one year.

干预措施: Rosuvastatin (Drug)

结局指标

主要结局

The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%)

时间窗: one-year

The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%)

次要结局

  • The change rate of TAV and plaque load of the target vascular lesion;(one-year)
  • The change rate of lipid composition of plaque: including the lipid volume , the maximum area and angle of lipid, the length of vulnerable plaque, etc.(one-year)
  • The change rates of other indexes (low density lipoprotein level, Lp-PLA2, hs-CRP, etc.)(one-year)
  • The change rates of lesion OFR and target vessel OFR(one-year)
  • The change rates of other components of plaque (fiber, calcification, crystal, macrophage)(one-year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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