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

Starting soon · Phase 3

Conditions studied: Acute Coronary Syndromes, Secondary Prevention, Lipids

In brief

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.

Key facts

Study ID

NCT07440381

Run by

Heart Care Foundation

People needed

600

Starts

2026-09-01

Expected to finish

2027-08-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 instability),
• Severe renal dysfunction (eGFR <30 ml/min/1.73m2 using the CKD-EPI formula),
• Active liver disease or hepatic dysfunction (AST or ALT levels > 3xUNL),
• Current enrolment in another investigational device or drug study,
• Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception,
• Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.

Where it is running

• Ospedale Miulli - U.O.C. CARDIOLOGIA - UTIC — Acquaviva delle Fonti, Italy
• Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic — Altamura, Italy
• Ospedale San Donato - U.O.C Cardiologia — Arezzo, Italy
• Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti' — Avellino, Italy
• Ospedale San Paolo - Cardiologia-Utic — Bari, Italy
• Ospedale Santo Spirito - SC Cardiologia — Casale Monferrato, Italy
• Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic — Caserta, Italy
• Azienda Ospedaliera Cannizzaro - Uoc Cardiologia — Catania, Italy
• OSPEDALE PIO XI - UOC di Cardiologia — Desio, Italy
• Presidio Ospedaliero "Santa Maria Del Prato" - U.O.C. Di Cardiologia-Utic — Feltre, Italy
• Arcispedale Sant'Anna - U.O. Cardiologia — Ferrara, Italy
• Aou Careggi - Interventistica Cardiologica Strutturale — Florence, Italy
• Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic — Foggia, Italy
• Ospedale Del Tigullio Polo Lavagna - Sc Cardiologia E Utic — Lavagna, Italy
• OSPEDALE CIVILE FORNAROLI - UO Cardiologia — Magenta, Italy
• Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica — Milan, Italy
• Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico - Uoc Malattie Cardiovascolari — Milan, Italy
• Irccs Ospedale Galeazzi - Sant'Ambrogio - Cardiologia Universitaria Ed Imaging Cardiaco — Milan, Italy
• Ospedale Policlinico - Uoc Di Cardiologia — Modena, Italy
• Aou Policlinico P. Giaccone - U.O.C. Cardiologia — Palermo, Italy
• Arnas P.O. Civico E Benfratelli - Uoc Utic — Palermo, Italy
• FONDAZIONE IRCCS POLICLINICO SAN MATTEO - UOC Cardiologia — Pavia, Italy
• Ospedale Santo Spirito - Cardiologia Con Utic — Pescara, Italy
• Ospedale San Jacopo - Soc Cardiologia — Pistoia, Italy
• Aor San Carlo - Ospedale San Carlo - Ssd Terapia Intensiva Cardiologica — Potenza, Italy

Full record on ClinicalTrials.gov

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