Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT06338293

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

NanJing Frist Hospital

Nanjing, Jiangsu, China, 210006

Actively Recruiting

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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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Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques | DecenTrialz