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NCT Number: NCT07824323

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

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.

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Dyslipidemia Dyslipidemias Heart Diseases Infarction Ischemia Lipid Metabolism Disorders Metabolic Diseases Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Nutritional and Metabolic Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taipei Medical University Hospital

Taipei, Taipei City, 110301, Taiwan

Location status: Recruiting

Location contact

Chun-Yao Huang, MD, PhD

CONTACT

[email protected]

+886-2-2737-2181 ext. 8603

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Participants Achieving LDL-C Below 55 mg/dL at Week 12

    Time frame: Week 12 (visit window: +/- 2 weeks)

    Proportion of randomized participants whose measured low-density lipoprotein cholesterol is below 55 mg/dL at the Week 12 assessment.

Secondary outcomes

  1. Absolute Change in LDL-C From Baseline to Week 12

    Time frame: Baseline and Week 12 (visit window: +/- 2 weeks)

    Week 12 LDL-C minus baseline LDL-C, reported in mg/dL.

  2. Percentage Change in LDL-C From Baseline to Week 12

    Time frame: Baseline and Week 12 (visit window: +/- 2 weeks)

    Percentage change calculated from baseline and Week 12 LDL-C measurements.

  3. Extremely High-Risk Participants Achieving LDL-C Below 40 mg/dL

    Time frame: Week 12 (visit window: +/- 2 weeks)

    Proportion of prespecified extremely high-risk participants with LDL-C below 40 mg/dL.

  4. Risk-Based LDL-C Goal Attainment

    Time frame: Week 12 (visit window: +/- 2 weeks)

    Proportion of extremely high-risk participants achieving LDL-C below 40 mg/dL together with the proportion of very high-risk participants achieving LDL-C below 55 mg/dL.

  5. Change in High-Sensitivity C-Reactive Protein

    Time frame: Baseline and Week 12 (visit window: +/- 2 weeks)

    Change in high-sensitivity C-reactive protein from baseline to Week 12.

  6. Participants With Treatment-Emergent Muscle-Related Adverse Events

    Time frame: From treatment initiation through Week 12

    Proportion of participants experiencing myalgia or myopathy after treatment initiation.

  7. Participants With Elevated Liver Enzymes

    Time frame: From treatment initiation through Week 12

    Proportion of participants with alanine aminotransferase or aspartate aminotransferase greater than 3 times the upper limit of normal.

  8. Participants With Clinically Significant Hyperuricemia or Symptomatic Gout

    Time frame: From treatment initiation through Week 12

    Proportion of participants with serum uric acid at least 2 mg/dL above the upper limit of normal or symptomatic gout.

  9. Participants With Gallbladder-Related Events

    Time frame: From treatment initiation through Week 12

    Proportion of participants with cholelithiasis or cholecystitis.

  10. Medication Adherence

    Time frame: Week 4 and Week 12

    Participant adherence assessed using self-report, prescription records, and pharmacy dispensing records.

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Yao Huang, MD, PhD

CONTACT

[email protected]

+886-2-2737-2181 ext. 8603

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Registry information

Official study title

EARLY-BIRD ACS Trial: Early Aggressive Lipid-Lowering Regimen With Bempedoic Acid Initiated for Reducing Dyslipidemia in Patients With Acute Coronary Syndrome

Acronym: EARLY-BIRD ACS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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