Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS
Summary
The study is prospective, open-label, randomized, single-center study involving patients admitted on an emergency basis with an acute coronary syndrome (ACS) clinic who underwent PCI of an infarct-related artery (IRA) and had intermediate coronary artery lesions (50-70% stenosis diameter) and elevated LDL-C ( \> 1.4 mmol/l) despite statin therapy at the highest dosage. Patients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg / day. Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day.
Timeline
- Start
- 2022-09-02
- Primary completion
- 2024-05
- Completion
- 2024-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alirocumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Evolocumab | Monoclonal antibody | 140 mg | Subcutaneous |
| Subject | Ezetimibe | Unknown | 10 mg | — |
| Background | Atorvastatin | Small molecule | 80 mg | — |
| Background | Rosuvastatin | Small molecule | 40 mg | — |