EARLY-BIRD ACS Trial: Early Aggressive Lipid-Lowering Regimen With Bempedoic Acid Initiated for Reducing Dyslipidemia in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Participants Achieving LDL-C Below 55 mg/dL at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and treating physicians are not masked. Endpoint assessors and investigators performing data analysis are masked to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Triple Lipid-Lowering Therapy
Participants will receive bempedoic acid, ezetimibe, and a high-intensity statin beginning within 72 hours after PCI and continuing for 12 weeks.
干预措施: High-Intensity Statin Therapy (Drug)
Dual Lipid-Lowering Therapy
Participants will receive ezetimibe and a high-intensity statin beginning within 72 hours after PCI and continuing for 12 weeks.
干预措施: High-Intensity Statin Therapy (Drug)
Triple Lipid-Lowering Therapy
Participants will receive bempedoic acid, ezetimibe, and a high-intensity statin beginning within 72 hours after PCI and continuing for 12 weeks.
干预措施: Ezetimibe (Drug)
Triple Lipid-Lowering Therapy
Participants will receive bempedoic acid, ezetimibe, and a high-intensity statin beginning within 72 hours after PCI and continuing for 12 weeks.
干预措施: bempedoic acid (Drug)
Dual Lipid-Lowering Therapy
Participants will receive ezetimibe and a high-intensity statin beginning within 72 hours after PCI and continuing for 12 weeks.
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Participants Achieving LDL-C Below 55 mg/dL at Week 12
时间窗: 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.
次要结局
- Absolute Change in LDL-C From Baseline to Week 12(Baseline and Week 12 (visit window: +/- 2 weeks))
- Percentage Change in LDL-C From Baseline to Week 12(Baseline and Week 12 (visit window: +/- 2 weeks))
- Extremely High-Risk Participants Achieving LDL-C Below 40 mg/dL(Week 12 (visit window: +/- 2 weeks))
- Risk-Based LDL-C Goal Attainment(Week 12 (visit window: +/- 2 weeks))
- Change in High-Sensitivity C-Reactive Protein(Baseline and Week 12 (visit window: +/- 2 weeks))
- Participants With Treatment-Emergent Muscle-Related Adverse Events(From treatment initiation through Week 12)
- Participants With Elevated Liver Enzymes(From treatment initiation through Week 12)
- Participants With Clinically Significant Hyperuricemia or Symptomatic Gout(From treatment initiation through Week 12)
- Participants With Gallbladder-Related Events(From treatment initiation through Week 12)
- Medication Adherence(Week 4 and Week 12)