Acute Coronary Syndromes, Dyslipidemia
Conditions
Keywords
Bempedoic acid, Low-density lipoprotein cholesterol, Percutaneous coronary intervention, ST-elevation myocardial infarction, Unstable angina, Non-ST-elevation myocardial infarction, Combination lipid-lowering therapy
Brief 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.
Detailed description
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.
Interventions
DRUGbempedoic acid
Bempedoic acid 180 mg tablet taken orally once daily for 12 weeks.
DRUGEzetimibe
Ezetimibe 10 mg tablet taken orally once daily for 12 weeks.
DRUGHigh-Intensity Statin Therapy
Atorvastatin 40 mg orally once daily or rosuvastatin 20 mg orally once daily for 12 weeks, selected according to clinical judgment and routine practice.
Sponsors
Taipei Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and treating physicians are not masked. Endpoint assessors and investigators performing data analysis are masked to treatment allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Achieving LDL-C Below 55 mg/dL at Week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in LDL-C From Baseline to Week 12 | Baseline and Week 12 (visit window: +/- 2 weeks) | Week 12 LDL-C minus baseline LDL-C, reported in mg/dL. |
| Percentage Change in LDL-C From Baseline to Week 12 | Baseline and Week 12 (visit window: +/- 2 weeks) | Percentage change calculated from baseline and Week 12 LDL-C measurements. |
| Extremely High-Risk Participants Achieving LDL-C Below 40 mg/dL | Week 12 (visit window: +/- 2 weeks) | Proportion of prespecified extremely high-risk participants with LDL-C below 40 mg/dL. |
| Risk-Based LDL-C Goal Attainment | 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. |
| Change in High-Sensitivity C-Reactive Protein | Baseline and Week 12 (visit window: +/- 2 weeks) | Change in high-sensitivity C-reactive protein from baseline to Week 12. |
| Participants With Treatment-Emergent Muscle-Related Adverse Events | From treatment initiation through Week 12 | Proportion of participants experiencing myalgia or myopathy after treatment initiation. |
| Participants With Elevated Liver Enzymes | From treatment initiation through Week 12 | Proportion of participants with alanine aminotransferase or aspartate aminotransferase greater than 3 times the upper limit of normal. |
| Participants With Clinically Significant Hyperuricemia or Symptomatic Gout | 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. |
| Participants With Gallbladder-Related Events | From treatment initiation through Week 12 | Proportion of participants with cholelithiasis or cholecystitis. |
| Medication Adherence | Week 4 and Week 12 | Participant adherence assessed using self-report, prescription records, and pharmacy dispensing records. |
Countries
Taiwan
Contacts
CONTACTChun-Yao Huang, MD, PhD
PRINCIPAL_INVESTIGATORChun-Yao Huang, MD, PhD
Taipei Medical University Hospital
Outcome results
None listed