Actively Recruiting
Using OFR Software to Observe the Effects of Inclisiran Combined With Statins on the Morphology and Vascular Function of Coronary Vulnerable Plaques
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-02-14
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of combining inclisiran with statins compared to statins alone on the shape and function of vulnerable plaques in the coronary arteries. The goal is to improve treatment and imaging methods for these plaques, which are important in coronary artery disease. Vulnerable plaques are difficult to fully assess with current imaging methods, so this study uses a new software tool to better evaluate plaque characteristics. Participants will be assigned randomly to one of two groups. One group will receive rosuvastatin 20 mg daily for one year along with three doses of inclisiran given by subcutaneous injection at the start, three months, and nine months. The other group will receive rosuvastatin 20 mg daily for one year without inclisiran. The study uses advanced imaging techniques and software to analyze plaque morphology and function throughout the year. During the study, participants will undergo detailed imaging and blood tests to measure plaque changes and blood markers related to heart disease. Researchers will track changes in plaque thickness, volume, and composition, as well as vessel function and blood lipid levels over one year. Safety and medication adherence will also be monitored. The study aims to provide better treatment options and more precise imaging information for patients with coronary artery disease.
CONDITIONS
Brief Title
Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Coronary angiography showing 20 to 70% diameter of the main coronary lesion
- Target lesion confirmed by OCT and OFR analysis with at least one vulnerable plaque (fibrous cap thickness 64 5 bcm and lipid core 65 90)
- Target vessel does not require further percutaneous coronary intervention (PCI)
- Patients treated with statins for at least 4 weeks but LDL-C remains 65 70 mg/dl (1.8 mmol/l)
You will not qualify if you...
- Acute myocardial infarction within the past 30 days
- Severely distorted or angulated coronary artery target lesion
- Severe left main artery lesion, chronic occlusive lesion, or bifurcation lesion
- Previous coronary artery bypass grafting (CABG)
- Serum triglycerides greater than 500 mg/dl (5.6 mmol/l)
- Severe heart failure (ejection fraction < 40%) or respiratory failure
- Severe renal insufficiency (eGFR < 30 ml/min/1.73 m2), active liver disease, or severe liver damage
- Allergy to statins or inclisiran, or prior use of PCSK9 monoclonal antibody
- Known active infection or severe blood, metabolic, or endocrine disorder
- Planned non-cardiac surgery within 12 months
- Inability to comply with follow-up or risk increased by participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants receive statins daily for one year. Those in the Inclisiran group also receive three subcutaneous injections of Inclisiran over the year.
3 injection visits plus daily medication; additional visits to monitor progress may occur
Duration - Up to 1 year after treatment
After treatment, participants are followed to observe changes in coronary vulnerable plaques and vascular function over one year.
Visits aligned with imaging and blood testing schedules during follow-up
Trial Site Locations
Total: 1 location
1
NanJing Frist Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
P
Peina Meng, MD
F
Fei Ye, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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