Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques

NCT ID: NCT06338293

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2025-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Inclisiran＋rosuvastatin group

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.

Group Type: EXPERIMENTAL

Inclisiran sodium

Intervention Type: DRUG

The patients in Inclisiran group were given drugs three times in total. The first needle was injected subcutaneously with 284mg(1.5ml solution) after entering the group, the second needle was injected three months later and the third needle was injected at the ninth month.

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin

Rosuvastatin group

Rosuvastatin group: Rosuvastatin 20mg daily for one year.

Group Type: PLACEBO_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin

Interventions

Inclisiran sodium

The patients in Inclisiran group were given drugs three times in total. The first needle was injected subcutaneously with 284mg(1.5ml solution) after entering the group, the second needle was injected three months later and the third needle was injected at the ninth month.

Intervention Type: DRUG

Rosuvastatin

Rosuvastatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Inclusion criteria: 1. Age 18-80 years old; 2. Coronary angiography (CAG) showed that the diameter of the primary coronary lesion was 20 ~ 70%, and the lesion was confirmed by OCT and OFR analysis, in which the target lesion contained at least one vulnerable plaque (the thinnest fibrous cap thickness was ≤65um, and the lipid core was ≥ 90), and the target vessel did not need further percutaneous coronary intervention (PCI); 3. Patients have been treated with statins for ≥4 weeks, but their LDL-C level were still ≥ 70 mg/dl (≥ 1.8 mmol/l).

Exclusion criteria: 1. Acute myocardial infarction occurred in recent 30 days; 2. The target lesion of coronary artery is severely distorted and angulated; Severe left main artery lesion, chronic occlusive lesion and bifurcation lesion; 3. Previous CABG; 4. Serum triglyceride (TG) > 500 mg/dl (> 5.6 mmol/l); 5. Patients with severe heart failure (< 40%) and respiratory failure; 6. Severe renal insufficiency (eGFR < 30ml ／min／1.73m2), active liver disease or severe liver damage;7. allergic to statins or inclisiran, and used PCSK9 monoclonal antibody in the past; 8. Known active infection or severe blood, metabolic or endocrine dysfunction; 9. Non-cardiac surgery is planned within 12 months; 10, can't follow the requirements of the follow-up, or researchers believe that the subjects to participate in the trial will increase the risk.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

China Jiangsu

Role: PRINCIPAL_INVESTIGATOR

Nanjin First Hospital,Nanjing Medical University

Locations

NanJing Frist Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peina Meng, MD

Role: CONTACT

527114121@qq.com

8615805199492

Fei Ye, MD

Role: CONTACT

doctor_ye@126.com

8618951670287

Facility Contacts

Meng Pei Na, Doctor

Role: primary

527114121@qq.com

86+15805199492

Other Identifiers

KY20240123-02

Identifier Type: -

Identifier Source: org_study_id