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Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography

RecruitingPhase 4Ages 18 Years - 65 YearsAllFirst Affiliated Hospital of Xinjiang Medical Uni…
NCT06520904 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease (CAD). However, the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD, evaluated through optical coherence tomography (OCT), remains inadequately understood. Moreover, there is a notable absence of relevant randomized controlled trials investigating this phenomenon. This current study represents a single-center, randomized, controlled, open-label trial conducted among Asian patients with early-onset CAD. Its principal objective was to explore the effects of PCSK9 inhibitors on coronary atherosclerotic plaque morphology as assessed by OCT.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Men aged 18-55 years and women aged 18-65 years; * CAD patients with coronary angiographically confirmed lesions in ≥2 vessels; at least one vessel was critically diseased (50-70% stenosis level); * LDL-C \>3.4 mmol/L without regular statin therapy or LDL-C \>1.8 mmol/L after 4 weeks of statin lipid-lowering therapy. Exclusion Criteria: * Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy; * Prior use of PCSK9 inhibitors; * Prior history of hemorrhagic stroke; * Prior coronary artery bypass grafting or coronary intervention; * Inability to perform OCT imaging or unclear imaging; * Severe renal insufficiency (creatinine clearance \< 30 mL/min); * Severe hepatic dysfunction; * Baseline triglycerides \> 5.6 mmol/L; * Pregnant or lactating women; * Life expectancy not exceeding 1 year; * In the judgment of the investigator, unsuitable for this study for any reason.
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What it tests

  • PCSK9 inhibitor
  • Statin
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Where

1 site
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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