Study of PCSK9 Inhibitors and Statin Therapy Effects on Coronary Artery Disease Plaques Using Optical Coherence Tomography in Adults with Early-Onset CAD

What this Trial Is About

Researchers are investigating the effects of PCSK9 inhibitors on coronary atherosclerotic plaques in patients with early-onset coronary artery disease CAD. This single-center, randomized, controlled, open-label Phase 4 trial focuses on Asian patients diagnosed with CAD who have vulnerable plaques detected through optical coherence tomography OCT. The study addresses a gap in understanding how PCSK9 inhibitors may stabilize plaques compared to intensive statin therapy alone. After initial percutaneous coronary intervention PCI for culprit lesions, patients with at least two additional lesions meeting lipid criteria undergo OCT imaging to assess plaque features such as calcification, fibrosis, fibrolipid deposition, necrosis, minimum fibrous cap thickness mFCT, and maximum lipid arc MLA. Participants are randomly assigned to receive either PCSK9 inhibitors combined with moderate-intensity statins or intensive statin therapy alone. After one year of treatment and follow-up, OCT imaging is repeated to compare changes in plaque morphology and stability between the two groups. Throughout the study, detailed clinical profiles, biochemical markers, imaging results, and cardiovascular events are recorded. Participants undergo OCT evaluations immediately after PCI and again at one year to measure outcomes including mFCT, MLA, calcification, fibrosis, fibrolipid deposition, and necrosis. This comprehensive monitoring aims to provide a thorough understanding of how these treatments impact coronary plaque characteristics and patient outcomes over the study period, which concludes in late 2026.

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