Overview
This randomized clinical trial will evaluate whether starting bempedoic acid in addition to high-intensity statin therapy and ezetimibe within 72 hours after percutaneous coronary intervention improves low-density lipoprotein cholesterol (LDL-C) control in adults with acute coronary syndrome. Participants will receive either triple therapy with a high-intensity statin, ezetimibe, and bempedoic acid or standard dual therapy with a high-intensity statin and ezetimibe for 12 weeks. The primary outcome is the proportion of participants with LDL-C below 55 mg/dL at Week 12. Changes in lipid and inflammatory markers, medication adherence, and treatment-emergent adverse events will also be assessed.
Description
EARLY-BIRD ACS is a prospective, randomized, open-label, blinded-endpoint, parallel-group clinical trial in adults with acute coronary syndrome who have undergone percutaneous coronary intervention (PCI). Eligible participants with baseline LDL-C of at least 70 mg/dL will be randomized 1:1 within 72 hours after PCI. The experimental group will receive bempedoic acid 180 mg once daily, ezetimibe 10 mg once daily, and either atorvastatin 40 mg once daily or rosuvastatin 20 mg once daily. The active-comparator group will receive ezetimibe 10 mg once daily and either atorvastatin 40 mg once daily or rosuvastatin 20 mg once daily. Treatment will continue for 12 weeks. Follow-up assessments will occur at Week 4 and Week 12. Laboratory measurements will be performed using standardized methods in certified hospital laboratories. The primary analysis will use the intention-to-treat population.
Eligibility
Inclusion Criteria:
- Age 18 years or older.
- Confirmed acute coronary syndrome, including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina.
- Percutaneous coronary intervention within the preceding 72 hours.
- Baseline LDL-C of at least 70 mg/dL.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Current use of a PCSK9 inhibitor or fibrate at baseline.
- History of symptomatic hyperuricemia or gout.
- Severe hepatic impairment, defined as ALT or AST greater than 3 times the upper limit of normal at screening.
- Known gallbladder disease, including cholelithiasis or previous cholecystitis.
- Known intolerance or contraindication to statins, ezetimibe, or bempedoic acid.
- Triglycerides of at least 400 mg/dL at screening.
- Estimated glomerular filtration rate below 30 mL/min/1.73 m2 or dialysis.
- Active systemic infection or acute inflammatory disease that could interfere with hs-CRP interpretation.
- Current participation in another interventional clinical trial.
- Pregnancy, breastfeeding, or planned pregnancy during the study period.
