Actively Recruiting
Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-02-14
40
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 shows primary coronary lesion diameter between 20% and 70%
- Target lesion confirmed by OCT and OFR to have at least one vulnerable plaque with fibrous cap thickness 64 5 micrometers and lipid core 75%
- Target vessel does not require further percutaneous coronary intervention (PCI)
- Patients treated with statins for at least 4 weeks but have LDL-C levels 65 70 mg/dl (1.8 mmol/l)
You will not qualify if you...
- Acute myocardial infarction within the past 30 days
- Target coronary artery lesion severely distorted or angulated
- Severe left main artery lesion, chronic occlusive lesion, or bifurcation lesion
- Previous coronary artery bypass graft (CABG) surgery
- Serum triglycerides above 500 mg/dl (5.6 mmol/l)
- Severe heart failure (ejection fraction below 40%) or respiratory failure
- Severe renal insufficiency (eGFR below 30 ml/min/1.73m2), active liver disease, or severe liver damage
- Allergy to statins or inclisiran, or previous use of PCSK9 monoclonal antibody
- Known active infection or severe blood, metabolic, or endocrine dysfunction
- Planned non-cardiac surgery within 12 months
- Unable to follow study requirements or participation increases risk according to researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NanJing Frist Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
P
Peina Meng, MD
CONTACT
F
Fei Ye, MD
CONTACT
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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