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Recruiting
NCT07824323
Early Triple Lipid-Lowering Therapy With Bempedoic Acid After Acute Coronary Syndrome
Conditions: Acute Coronary Syndromes, Dyslipidemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 400
Sponsor: Taipei Medical University Hospital
Location: Taipei Medical University Hospital Taipei Taipei City
Summary
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.
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.
Source: ClinicalTrials.gov (NCT07824323). StuddyBuddy aggregates publicly available trial information.