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Clinical Trials in Italy / NCT07440381
Starting soon Phase 3

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

NCT07440381 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2026-09
Last updated
2026-02-27

Condition(s) studied

Acute Coronary SyndromesSecondary PreventionLipids

Investigational drug(s) / intervention(s)

Triple oral lipid lowering treatment

Triple oral lipid lowering treatment: Triple oral lipid lowering treatment including high intensity statin, ezetimibe and bembedoic acid

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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.

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
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
Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic Ragusa Italy
Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera Reggio Emilia Italy
OSPEDALE DEGLI INFERMI - SC Cardiologia Rivoli Italy
Ospedale San Camillo - Uoc Cardiologia Roma Italy
P.O. San Filippo Neri - Asl Roma 1 - Cardiologia Clinica E Riabilitativa Roma Italy
PRESIDIO OSPEDALIERO - UO Cardiologia Sanremo Italy
P.O. Levante - Ospedale San Paolo - S.C. Cardiologia Levante Savona Italy
OSPEDALE SANTA CHIARA - Divisione di Cardiologia Trento Italy
OSPEDALE CA' FONCELLO - UOC Cardiologia Treviso Italy
Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic Vimercate Italy

More Heart Care Foundation trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07440381 on ClinicalTrials.gov ↗ ← All trials in Italy