triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE
Key facts
- Where
- Acquaviva delle Fonti, Alexandria, Arezzo, Avellino, Bari, Caserta, Catania, Chiavari, Feltre, Ferrara, Florence, Foggia, Legnano, Milan, Modena, Palermo, Pavia, Pescara, Pistoia, Ragusa, Reggio Emilia, Rivoli, Rome, Savona, Trento, Treviso, and Vimercate, ItalySee the 30 sites
- Phase
- Phase 3
Where in Italy
- Ente Ecclesiastico ospedale generale Regionale MiulliAcquaviva delle Fonti, ItalyNot yet recruiting
- Azienda Sanitaria Locale Al Di AlessandriaAlexandria, ItalyNot yet recruiting
- Azienda Unita' Sanitaria Locale Toscana Sud EstArezzo, ItalyNot yet recruiting
- AORN San Giuseppe Moscati AvellinoAvellino, ItalyNot yet recruiting
- Azienda Sanitaria Locale BariBari, ItalyNot yet recruiting
- Azienda Ospedaliera Sant'Anna E San Sebastiano Di CasertaCaserta, ItalyNot yet recruiting
- Azienda Ospedaliera per l Emergenza CannizzaroCatania, ItalyNot yet recruiting
- Azienda Sociosanitaria Ligure N 4 Sistema Sanitario Regione LiguriaChiavari, ItalyNot yet recruiting
- Azienda Unita Locale Socio Sanitaria N. 1 DolomitiFeltre, ItalyNot yet recruiting
- University Hospital Of FerraraFerrara, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyNot yet recruiting
- Azienda Socio Sanitaria Territoriale Ovest MilaneseLegnano, ItalyNot yet recruiting
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyNot yet recruiting
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyNot yet recruiting
- Ospedale Galeazzi S.p.A.Milan, ItalyNot yet recruiting
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyNot yet recruiting
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyNot yet recruiting
- Azienda Sanitaria Locale di PescaraPescara, ItalyNot yet recruiting
- Azienda USL Toscana CentroPistoia, ItalyNot yet recruiting
- Azienda Sanitaria Provinciale Di RagusaRagusa, ItalyNot yet recruiting
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyNot yet recruiting
- Azienda Sanitaria Locale TO3Rivoli, ItalyNot yet recruiting
- Azienda Sanitaria Locale Roma 1Rome, ItalyNot yet recruiting
- San Camillo Forlanini HospitalRome, ItalyNot yet recruiting
- Azienda Sociosanitaria Ligure 2Savona, ItalyNot yet recruiting
- Azienda Sanitaria Universitaria Integrata Del TrentinoTrento, ItalyNot yet recruiting
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca TrevigianaTreviso, ItalyNot yet recruiting
- Azienda Socio Sanitaria Territoriale Della BrianzaVimercate, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heart Care Foundation
- Trial code
- NCT07440381EU 2026-525740-15-00
- Record updated
- 27 February 2026
- Original description
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.Read full original descriptionShow less
triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE (PERSUADE) Trial
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.
Inclusion: 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: Patients already treated with HIS+Ezetimibe on admission for the ACS event,; Patients currently, previously or planned to be treated with PCSK9i or inclisiran,; Current enrolment in another investigational device or drug study,; 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 plasma triglycerides concentration exceeding 400 mg/dL (4.52 mmol/L),; 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),; Patients treated currently or in the last 3 months with bempedoic acid or in whom this treatment is planned in the following 8 weeks,; Patients with known Familial Hypercholesterolemia (FH; heterozygous or homozygous),; Patients with dysbetalipoproteinemia (type III hyperlipoproteinemia),; Unstable clinical status (hemodynamic or electrical instability),; 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.