Effects of Inclisiran Combined with Statins on the Morphology of Coronary Vulnerable Plaques
- Conditions
- Coronary Artery Disease
- Interventions
- Registration Number
- NCT06338293
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inclisiran＋rosuvastatin group Inclisiran sodium 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. Inclisiran＋rosuvastatin group Rosuvastatin 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. Rosuvastatin group Rosuvastatin Rosuvastatin group: Rosuvastatin 20mg daily for one year.
- Primary Outcome Measures
Name Time Method The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%) 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%)
- Secondary Outcome Measures
Name Time Method The change rate of TAV and plaque load of the target vascular lesion; one-year The change rate of TAV and plaque load of the target vascular lesion from baseline to one-year follow-up;
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 rate of lipid composition of plaque: including the lipid volume from baseline to one-year follow-up , the maximum area and angle of lipid from baseline to one-year follow-up, the length of vulnerable plaque from baseline to one-year follow-up, etc.
The change rates of other indexes (low density lipoprotein level, Lp-PLA2, hs-CRP, etc.) one-year The change rates of other indexes from baseline to one-year follow-up(low density lipoprotein level, Lp-PLA2, hs-CRP, etc.)
The change rates of lesion OFR and target vessel OFR one-year The change rates of lesion OFR and target vessel OFR from baseline to one-year follow-up
The change rates of other components of plaque (fiber, calcification, crystal, macrophage) one-year The change rates of other components of plaque from baseline to one-year follow-up (fiber, calcification, crystal, macrophage)
Trial Locations
- Locations (1)
NanJing Frist Hospital
🇨🇳Nanjing, Jiangsu, China