Acute Coronary SyndromesPhase 4EARLY-BIRD ACSNCT07824323
Early Triple Lipid-Lowering Therapy With Bempedoic Acid After Acute Coronary Syndrome
A Phase 4 study testing bempedoic acid, Ezetimibe and High-Intensity Statin Therapy in people with Acute Coronary Syndromes and Dyslipidemia, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes, Dyslipidemia
- What is being tested?
- bempedoic acid, Ezetimibe and High-Intensity Statin Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Aug 2026to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, Taipei City, 110301
Chun-Yao Huang, MD, PhD, +886-2-2737-2181 ext. 8603, cyhuang@tmu.edu.tw
About this study
Official title: EARLY-BIRD ACS Trial: Early Aggressive Lipid-Lowering Regimen With Bempedoic Acid Initiated for Reducing Dyslipidemia in Patients With 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.
Read the 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.
- Conditions
- Acute Coronary Syndromes, Dyslipidemia
- Being tested
- bempedoic acid, Ezetimibe, High-Intensity Statin Therapy
- 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
- Medical subject headings
- Acute Coronary Syndrome, Dyslipidemias, ST Elevation Myocardial Infarction, Angina, Unstable, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bempedoic acidDrug
Bempedoic acid 180 mg tablet taken orally once daily for 12 weeks.
EzetimibeDrug
Ezetimibe 10 mg tablet taken orally once daily for 12 weeks.
High-Intensity Statin TherapyDrug
Atorvastatin 40 mg orally once daily or rosuvastatin 20 mg orally once daily for 12 weeks, selected according to clinical judgment and routine practice.
| Study group | Role | What they receive |
|---|---|---|
| Triple Lipid-Lowering Therapy | Experimental | Participants will receive bempedoic acid, ezetimibe, and a high-intensity statin beginning within 72 hours after PCI and continuing for 12 weeks. Receives: Drug: bempedoic acid; Drug: Ezetimibe; Drug: High-Intensity Statin Therapy |
| Dual Lipid-Lowering Therapy | Active comparator | Participants will receive ezetimibe and a high-intensity statin beginning within 72 hours after PCI and continuing for 12 weeks. Receives: Drug: Ezetimibe; Drug: High-Intensity Statin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12 (visit window: +/- 2 weeks)
Secondary outcomes (10)
Absolute Change in LDL-C From Baseline to Week 12
Week 12 LDL-C minus baseline LDL-C, reported in mg/dL.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From treatment initiation through Week 12
Participants With Gallbladder-Related Events
Proportion of participants with cholelithiasis or cholecystitis.
Measured: From treatment initiation through Week 12
Medication Adherence
Participant adherence assessed using self-report, prescription records, and pharmacy dispensing records.
Measured: Week 4 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start26 Aug 2026
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yao Huang, MD, PhD, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824323
- Sponsor's protocol ID
- N202604111
- Acronym
- EARLY-BIRD ACS
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY-BIRD ACS Trial: Early Aggressive Lipid-Lowering Regimen With Bempedoic Acid Initiated for Reducing Dyslipidemia in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07824323
- Acronym / sponsor ID
- EARLY-BIRD ACS / N202604111
- Conditions
- Acute Coronary Syndromes, Dyslipidemia
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple Lipid-Lowering Therapy | Experimental | Drug: bempedoic acid, Drug: Ezetimibe, Drug: High-Intensity Statin TherapyParticipants will receive bempedoic acid, ezetimibe, and a high-intensity statin beginning within 72 hours after PCI and continuing for 12 weeks. |
| Dual Lipid-Lowering Therapy | Active comparator | Drug: Ezetimibe, Drug: High-Intensity Statin TherapyParticipants will receive ezetimibe and a high-intensity statin beginning within 72 hours after PCI and continuing for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bempedoic acidBempedoic acid 180 mg tablet taken orally once daily for 12 weeks. | Drug | Triple Lipid-Lowering Therapy |
| EzetimibeEzetimibe 10 mg tablet taken orally once daily for 12 weeks. | Drug | Dual Lipid-Lowering Therapy, Triple Lipid-Lowering Therapy |
| High-Intensity Statin TherapyAtorvastatin 40 mg orally once daily or rosuvastatin 20 mg orally once daily for 12 weeks, selected according to clinical judgment and routine practice. | Drug | Dual Lipid-Lowering Therapy, Triple Lipid-Lowering Therapy |
Primary outcome
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.
10 secondary outcomes
Absolute Change in LDL-C From Baseline to Week 12
Time frame: Baseline and Week 12 (visit window: +/- 2 weeks)
Percentage Change in LDL-C From Baseline to Week 12
Time frame: Baseline and Week 12 (visit window: +/- 2 weeks)
Extremely High-Risk Participants Achieving LDL-C Below 40 mg/dL
Time frame: Week 12 (visit window: +/- 2 weeks)
Risk-Based LDL-C Goal Attainment
Time frame: Week 12 (visit window: +/- 2 weeks)
Change in High-Sensitivity C-Reactive Protein
Time frame: Baseline and Week 12 (visit window: +/- 2 weeks)
Participants With Treatment-Emergent Muscle-Related Adverse Events
Time frame: From treatment initiation through Week 12
Participants With Elevated Liver Enzymes
Time frame: From treatment initiation through Week 12
Participants With Clinically Significant Hyperuricemia or Symptomatic Gout
Time frame: From treatment initiation through Week 12
Participants With Gallbladder-Related Events
Time frame: From treatment initiation through Week 12
Medication Adherence
Time frame: Week 4 and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chun-Yao Huang, MD, PhD principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bempedoic acid, Ezetimibe and High-Intensity Statin Therapy in people with Acute Coronary Syndromes and Dyslipidemia, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun-Yao Huang, MD, PhD (+886-2-2737-2181 ext. 8603, cyhuang@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Achieving LDL-C Below 55 mg/dL at Week 12 (time frame: Week 12 (visit window: +/- 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.