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

Phase 4RecruitingNCT07824323

Taipei Medical University Hospital400 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

400

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

Absolute Change in LDL-C From Baseline to Week 12

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

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

Percentage Change in LDL-C From Baseline to Week 12

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

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

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

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

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

Risk-Based LDL-C Goal Attainment

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.

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

Change in High-Sensitivity C-Reactive Protein

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

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

Participants With Treatment-Emergent Muscle-Related Adverse Events

Proportion of participants experiencing myalgia or myopathy after treatment initiation.

Time frame: From treatment initiation through Week 12

Participants With Elevated Liver Enzymes

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

Time frame: From treatment initiation through Week 12

Participants With Clinically Significant Hyperuricemia or Symptomatic Gout

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

Time frame: From treatment initiation through Week 12

Participants With Gallbladder-Related Events

Proportion of participants with cholelithiasis or cholecystitis.

Time frame: From treatment initiation through Week 12

Medication Adherence

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

Time frame: Week 4 and Week 12

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts