triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE
PERSUADE
1 other identifier
interventional
600
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2026
Shorter than P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
Study Completion
Last participant's last visit for all outcomes
August 1, 2027
February 27, 2026
February 1, 2026
11 months
February 20, 2026
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean percent change in LDL-c levels
the difference in the mean percent change in LDL-c levels from baseline at 8 weeks between triple combo therapy and usual care.
8 weeks
Secondary Outcomes (7)
Percentage of patients with LDL-c level <70 mg/dL
8 weeks
Percentage of patients with LDL-c level <55 mg/dL
8 weeks
Percentage of patients with LDL-c level <40 mg/dL in those with a recurrent ACS event in the previous 48 months
8 weeks
Change in high-sensitivity CRP (hs-CRP)
8 weeks
Persistence of active treatment and discontinuation rate
8 weeks
- +2 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONUsual Care
High intensity statin plus ezetimibe plus bempedoic acid
EXPERIMENTALpatients will receive a triple oral lipid lowering therapy including a high intensity statin, ezetimibe and bempedoic acid
Interventions
Triple oral lipid lowering treatment including high intensity statin, ezetimibe and bembedoic acid
Eligibility Criteria
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 (naĂ¯ve 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Furio Colivicchi, MD
San Filippo neri Hospital - Rome
- STUDY CHAIR
Aldo P Maggioni, MD
Fondazione per il Tuo cuore
- STUDY CHAIR
Pietro Scicchitano, MD
Ospedale Miulli - Bari
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2026
First Posted
February 27, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share