Effects of Inclisiran and Statins on Vulnerable Coronary Plaques

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

This study is testing whether a combination of inclisiran and statins can improve the health of dangerous cholesterol plaques in the arteries of people with coronary artery disease.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06338293 on ClinicalTrials.gov

What this trial studies

This study investigates the combined effects of inclisiran and statins on the morphology and vascular function of vulnerable coronary plaques in patients with coronary artery disease. It aims to utilize advanced imaging techniques, including OCT, IVUS, and FFR, to better identify and treat these plaques. By analyzing the data from these multimodal detection methods, the study seeks to provide a clearer understanding of plaque characteristics and improve treatment outcomes. Participants will be monitored for changes in plaque morphology and function following treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with coronary artery lesions showing vulnerable plaques who have been on statin therapy but still have elevated LDL-C levels.

Not a fit: Patients with recent acute myocardial infarction, severe coronary artery distortions, or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with coronary artery disease, potentially stabilizing vulnerable plaques and reducing the risk of heart attacks.

How similar studies have performed: Other studies have shown promise in using multimodal imaging techniques for assessing coronary plaques, but the specific combination of inclisiran and statins in this context is relatively novel.

Eligibility 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.

Where this trial is running

Nanjing, Jiangsu

• NanJing Frist Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: China Jiangsu — Nanjin First Hospital,Nanjing Medical University
• Study coordinator: Peina Meng, MD

Conditions Coronary Artery Disease