Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography in Patients With Premature Coronary Artery Disease: a Randomized Controlled Trial
First Affiliated Hospital of Xinjiang Medical University
396 participants
Jul 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria11
- 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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Interventions
PCSK9 inhibitors combined with moderate-intensity statin therapy
Intensive statin therapy
Locations(1)
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NCT06520904