NCT06520904

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: First Affiliated Hospital of Xinjiang Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Following initial percutaneous coronary intervention (PCI) for culprit lesions in patients with early-onset coronary artery disease (CAD) and ≥2 additional lesions meeting baseline lipid criteria, optical coherence tomography (OCT) was employed to evaluate non-culprit lesion sites for detailed characterization of plaque features including calcification, fibrosis, fibrolipid deposition, necrosis, minimum fibrous cap thickness (mFCT), and maximum lipid arc (MLA). Subsequently, patients were randomized in a 1:1 ratio to receive either intensive statin therapy alone or a combination of PCSK9 inhibitor with moderate-intensity statin therapy, using a random number allocation method. After 1 year of treatment and follow-up, OCT reassessment of non-culprit vessel critical lesions was conducted, documenting plaque characteristics such as calcification, fibrosis, fibrolipid content, necrosis, as well as stability parameters like mFCT and MLA at lesion sites. OCT findings were compared longitudinally within each treatment group and between groups receiving PCSK9 inhibitor combined with statin therapy versus intensive statin therapy alone. Baseline clinical profiles, biochemical markers, imaging findings, and incidence of adverse cardiovascular events during the follow-up period were also meticulously recorded for all enrolled early-onset CAD patients.

Conditions

• Coronary Artery Disease
• Optical Coherence Tomography

Interventions

Type	Name	Description
DRUG	PCSK9 inhibitor	PCSK9 inhibitors combined with moderate-intensity statin therapy
DRUG	Statin	Intensive statin therapy

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2024-07-25
• Last updated: 2024-08-19

Locations

1 site across 1 country: China