drugset / Trial / NCT06791031
PCSK9 inhibitoRs for Early Passivation of coRonary athEroSclerotic plaqueS in Acute Coronary Syndromes (REPRESS)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |