Early Triple Lipid-Lowering Therapy With Bempedoic Acid After Acute Coronary Syndrome
Recruiting · NCT07824323 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Taipei Medical University Hospital - Taipei, Taipei City, Taiwan