Early Intensive Lipid-Lowering With Inclisiran for Plaque Stabilization in Acute Coronary Syndrome
Summary
This multicenter, randomized, open-label clinical trial will evaluate whether an early intensive lipid-lowering strategy can improve coronary plaque stabilization in patients hospitalized with acute coronary syndrome. A total of 294 participants will be randomly assigned in a 1:1 ratio to either an early intensive treatment strategy with a high-intensity statin, ezetimibe, and inclisiran, or a guideline-based stepwise lipid-lowering strategy. Coronary plaque characteristics will be assessed using optical coherence tomography (OCT) at baseline and at 12 months. The primary outcome is the change in minimal fibrous cap thickness from baseline to 12 months. Additional assessments will include other OCT-based plaque characteristics, lipid levels, safety outcomes, and, in a subset of participants, intravascular ultrasound measurements of plaque burden.
Timeline
- Start
- 2026-09
- Primary completion
- 2029-09
- Completion
- 2029-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezetimibe | Unknown | 10 mg | Oral |
| Subject | Inclisiran | Small interfering RNA (siRNA) | 284 mg | Subcutaneous |
| Background | Atorvastatin | Small molecule | 40 mg | Oral |
| Background | Atorvastatin | Small molecule | 80 mg | Oral |
| Background | Rosuvastatin | Small molecule | 20 mg | Oral |