Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability Assessed by Optical Coherence Tomography
Status:
Completed
Trial end date:
2021-03-01
Target enrollment:
Participant gender:
Summary
The study is a prospective, open-label, randomized, single-center study involving patients
with intermediate coronary lesions (50%-70% diameter stenosis) and who have elevated LDL-C
values (LDL-C≥100 mg/dL) despite stable statin therapy.
Eligible patients are randomized to receive either alirocumab or standard-of-care (1:1). The
last dose of alirocumab will be given at week 34. Patients in the alirocumab arm will receive
alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin
10mg/day). Patients in the standard-of-care arm will continue to receive atorvastatin 20
mg/day or rosuvastatin 10 mg/day. OCT images will be acquired at the baseline and at week 36
± 2 weeks follow-up.