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RECRUITING Phase 4 ClinicalTrials.gov

Early Triple Lipid-Lowering Therapy With Bempedoic Acid After Acute Coronary Syndrome

Sponsor: Taipei Medical University Hospital • ClinicalTrials.gov ID: NCT07824323

Registry updated: 2026-09-17
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Description

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.

Interventions

  • bempedoic acid (Drug)
    Bempedoic acid 180 mg tablet taken orally once daily for 12 weeks.
  • Ezetimibe (Drug)
    Ezetimibe 10 mg tablet taken orally once daily for 12 weeks.
  • High-Intensity Statin Therapy (Drug)
    Atorvastatin 40 mg orally once daily or rosuvastatin 20 mg orally once daily for 12 weeks, selected according to clinical judgment and routine practice.

Eligibility criteria

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.

Conditions

Acute Coronary Syndromes Dyslipidemia

Locations

  • Taipei Medical University Hospital — Taipei, Taipei City, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record