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