A Phase 4 interventional study of bempedoic acid and Ezetimibe in Acute Coronary Syndromes and Dyslipidemia, sponsored by Taipei Medical University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Taipei Medical University Hospital · Phase 4, Interventional, and Treatment
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.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 400 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Taipei Medical University Hospital is the lead sponsor of 64 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive bempedoic acid, ezetimibe, and a high-intensity statin beginning within 72 hours after PCI and continuing for 12 weeks.
Drug: bempedoic acid · Drug: Ezetimibe · Drug: High-Intensity Statin Therapy
Participants will receive ezetimibe and a high-intensity statin beginning within 72 hours after PCI and continuing for 12 weeks.
Drug: Ezetimibe · Drug: High-Intensity Statin Therapy
Bempedoic acid 180 mg tablet taken orally once daily for 12 weeks.
Ezetimibe 10 mg tablet taken orally once daily for 12 weeks.
Atorvastatin 40 mg orally once daily or rosuvastatin 20 mg orally once daily for 12 weeks, selected according to clinical judgment and routine practice.
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)
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
Plan to share: No
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Studies of the drug tested here: Bempedoic acid
Taipei Medical University Hospital