Not Yet RecruitingPhase 3

triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE

Italy600 participantsStarted 2026-09

Plain-language summary

Early and intensive LDL-cholesterol (LDL-c) reduction is associated with improved short-term and long-term outcomes. Bempedoic acid is an oral ATP citrate lyase inhibitor that lowers LDL-c upstream of HMG-CoA reductase. When added to maximally tolerated statins, it has demonstrated significant LDL-c reduction and cardiovascular benefit, particularly in statin-intolerant or high-risk patients. However, evidence on early initiation of bempedoic acid during the index ACS hospitalization is currently lacking. The investigators therefore would like to see whether early (pre-discharge) initiation of an oral triple lipid-lowering therapy including bempedoic acid, high-intensity statin (HIS), and ezetimibe is superior to usual care in reducing LDL-c levels at 8 weeks after randomization in patients hospitalized for ACS.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years * Male and females at birth * Admitted for ACS caused by an atherothrombotic coronary event; * Calculated LDL-c: 70-140 mg/dL within 24 hours from admission for the ACS index event * Lipid lowering therapy on admission consisting of a low/moderate intensity statin or a high intensity statin (HIS); or no lipid lowering therapy (naïve patients) * Lipid-lowering therapy at discharge (at the time of randomization) consisting of HIS or HIS + ezetimibe * Scheduled home discharge * Written informed consent provided; patients who are unable to give informed consent for any reason will be excluded from the study. Exclusion Criteria: * Patients already treated with HIS+Ezetimibe on admission for the ACS event, * Patients currently, previously or planned to be treated with PCSK9i or inclisiran, * Patients treated currently or in the last 3 months with bempedoic acid or in whom this treatment is planned in the following 8 weeks, * Known allergy, sensitivity or intolerance to bempedoic acid and/or study drugs' formulation ingredients (e.g. lactose intolerance), * Patients with history of documented intolerance to statins, ezetimibe or bempedoic acid * Patients with known Familial Hypercholesterolemia (FH; heterozygous or homozygous), * Patients with plasma triglycerides concentration exceeding 400 mg/dL (4.52 mmol/L), * Patients with dysbetalipoproteinemia (type III hyperlipoproteinemia), * Unstable clinical status (hemodynamic or electrical instabil…

What they're measuring

Mean percent change in LDL-c levels

Timeframe: 8 weeks

Trial details

NCT IDNCT07440381

SponsorHeart Care Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Francesco Orso, MD

+390555101230 persuade@heartcarefoundation.it