drugset / Trial / NCT06791031

PCSK9 inhibitoRs for Early Passivation of coRonary athEroSclerotic plaqueS in Acute Coronary Syndromes (REPRESS)

NCT06791031 ↗

Not yet recruiting 212 enrolled West China Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

In this prospective, multicenter, open-label trial, 212 ACS patients will be randomized 1:1 to either the "PCSK9i early" intensified therapy group (initial addition of PCSK9i to moderate-intensity statin) or the guideline-directed medical therapy group for 6 months. Serial OCT imaging of non-culprit arteries (20-70% stenosis) is performed at baseline and 6 months. The primary endpoint is the absolute change in minimum fibrous cap thickness at 6 months, and secondary endpoints including changes in lumen area, lipid arc, macrophage infiltration, LDL-C reduction, and target LDL-C achievement.

Timeline

Start
2026-01
Primary completion
2027-12
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Alirocumab Monoclonal antibody 75 mg Subcutaneous
Subject Evolocumab Monoclonal antibody 140 mg Subcutaneous
Subject Inclisiran Small interfering RNA (siRNA) 300 mg —
Background Atorvastatin Small molecule 20 mg —
Background Rosuvastatin Small molecule 10 mg —