Effects of Inclisiran and Statins on Vulnerable Coronary Plaques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• NanJing Frist Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: China Jiangsu — Nanjin First Hospital,Nanjing Medical University
• Study coordinator: Peina Meng, MD
• Email: 527114121@qq.com
• Phone: 8615805199492

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.