PCSK9 inhibitor: PCSK9 inhibitors combined with moderate-intensity statin therapy
Statin: Intensive statin therapy
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
mFCT — Immediate and 1 year after PCI minimum fibrous cap thickness
MLA — Immediate and 1 year after PCI maximum lipid arc
Calcification — Immediate and 1 year after PCI calcification
Fibrosis — Immediate and 1 year after PCI fibrosis
Fibrolipid deposition — Immediate and 1 year after PCI fibrolipid deposition
Necrosis — Immediate and 1 year after PCI necrosis
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital of Xinjiang Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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