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Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques
RECRUITINGPhase 4Sponsored by Nanjing First Hospital, Nanjing Medical University
Actively Recruiting
PhasePhase 4
SponsorNanjing First Hospital, Nanjing Medical University
Started2024-03-15
Est. completion2025-06-30
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06338293
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.
Eligibility
Age: 18 Years – 80 YearsHealthy volunteers accepted
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.
Conditions2
Coronary Artery DiseaseHeart Disease
Interventions2
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Actively Recruiting
PhasePhase 4
SponsorNanjing First Hospital, Nanjing Medical University
Started2024-03-15
Est. completion2025-06-30
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06338293