Health TrialsbyHealthPanel

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

ConditionsAcute Coronary SyndromesDyslipidemia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Medical University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • bempedoic acid

    Drug

    Bempedoic acid 180 mg tablet taken orally once daily for 12 weeks.

  • Ezetimibe

    Drug

    Ezetimibe 10 mg tablet taken orally once daily for 12 weeks.

  • High-Intensity Statin Therapy

    Drug

    Atorvastatin 40 mg orally once daily or rosuvastatin 20 mg orally once daily for 12 weeks, selected according to clinical judgment and routine practice.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Triple Lipid-Lowering TherapyExperimental treatment 3 interventions
Group B: Dual Lipid-Lowering TherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Medical University Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now