Acute Coronary SyndromesPhase 3PERSUADENCT07440381
triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE
A Phase 3 study testing Triple oral lipid lowering treatment in people with Acute Coronary Syndromes and Secondary Prevention, run by Heart Care Foundation at 35 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes, Secondary Prevention, Lipids
- What is being tested?
- Triple oral lipid lowering treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 35 sitesItaly
- Study dates
- Sep 2026to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
35 sites in 1 country. Contact the study team or a site near you to ask about taking part.
35 sites in 1 country
Italy35 sites
Ospedale Miulli - U.O.C. CARDIOLOGIA - UTIC
Acquaviva delle Fonti
Massimo Grimaldi, MD, m.grimaldi@miulli.it
Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic
Altamura
Pietro Scicchitano, MD, pietro.scicchitano@asl.bari.it
Ospedale San Donato - U.O.C Cardiologia
Arezzo
Alessandra Sabini, MD, alesabini@hotmail.com
Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti'
Avellino
Francesca Lanni, MD, francesca.lanni@aornmoscati.it
Ospedale San Paolo - Cardiologia-Utic
Bari
Cosimo Campanella, MD, cosimocamp@gmail.com
Ospedale Santo Spirito - SC Cardiologia
Casale Monferrato
Federico Nardi, MD, fnardi@aslal.it
Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic
Caserta
Paolo Calabrò, MD, paolo.calabro@unicampania.it
Azienda Ospedaliera Cannizzaro - Uoc Cardiologia
Catania
Simona Giubilato, MD, simogiub@hotmail.com
OSPEDALE PIO XI - UOC di Cardiologia
Desio
Felice Achilli, MD, felice.achilli@asst-brianza.it
Presidio Ospedaliero "Santa Maria Del Prato" - U.O.C. Di Cardiologia-Utic
Feltre
Christian Piergentili, MD, christian.piergentili@aulss1.veneto.it
Arcispedale Sant'Anna - U.O. Cardiologia
Ferrara
Gabriele Guardigli, MD, grdgrl@unife.it
Aou Careggi - Interventistica Cardiologica Strutturale
Florence
Francesco Meucci, MD, francescomeu19@gmail.com
Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic
Foggia
Natale D Brunetti, MD, natale.brunetti@unifg.it
Ospedale Del Tigullio Polo Lavagna - Sc Cardiologia E Utic
Lavagna
Guido Parodi, MD, guido.parodi@asl4.liguria.it
OSPEDALE CIVILE FORNAROLI - UO Cardiologia
Magenta
Alessandra Russo, MD, alessandra.russo@asst-ovestmi.it
Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica
Milan
Giovanna Viola, MD, giovanna.viola@ospedaleniguarda.it
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico - Uoc Malattie Cardiovascolari
Milan
Stefano Carugo, MD, stefano.carugo@unimi.it
Irccs Ospedale Galeazzi - Sant'Ambrogio - Cardiologia Universitaria Ed Imaging Cardiaco
Milan
Daniele Andreini, MD, daniele.andreini@unimi.it
Ospedale Policlinico - Uoc Di Cardiologia
Modena
Guseppe Boriani, MD, giuseppe.boriani@unimore.it
Aou Policlinico P. Giaccone - U.O.C. Cardiologia
Palermo
Alfredo R Galassi, MD, alfredo.galassi@unipa.it
Arnas P.O. Civico E Benfratelli - Uoc Utic
Palermo
Ignazio M Smecca, MD, ignaziomaria.smecca@arnascivico.it
FONDAZIONE IRCCS POLICLINICO SAN MATTEO - UOC Cardiologia
Pavia
Leonardo De Luca, MD, l.deluca@smatteo.pv.it
Ospedale Santo Spirito - Cardiologia Con Utic
Pescara
Massimo Di Marco, MD, massimo.dimarco@asl.pe.it
Ospedale San Jacopo - Soc Cardiologia
Pistoia
Paola Angelotti, MD, paola.Angelotti@uslcentro.toscana.it
Aor San Carlo - Ospedale San Carlo - Ssd Terapia Intensiva Cardiologica
Potenza
Pasqualino Innelli, MD, pasquale.innelli@gmail.com
Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic
Ragusa
Antonino Nicosia, MD, antonino.nicosia@asp.rg.it
Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera
Reggio Emilia
Alessandro Navazio, MD, alessandro.navazio@ausl.re.it,a.navazio@iol.it
OSPEDALE DEGLI INFERMI - SC Cardiologia
Rivoli
Emanuele Tizzani, MD, etizzani@aslto3.piemonte.it
Ospedale San Camillo - Uoc Cardiologia
Roma
Domenico Gabrielli, MD, dgabrielli@scamilloforlanini.rm.it
P.O. San Filippo Neri - Asl Roma 1 - Cardiologia Clinica E Riabilitativa
Roma
Furio Colivicchi, MD, furio.colivicchi@aslroma1.it
PRESIDIO OSPEDALIERO - UO Cardiologia
Sanremo
Fabio Ferrari, MD, ferrari.cardiologo@gmail.com
P.O. Levante - Ospedale San Paolo - S.C. Cardiologia Levante
Savona
Alberto Somaschini, MD, alberto.somaschini08@gmail.com
OSPEDALE SANTA CHIARA - Divisione di Cardiologia
Trento
Michela Saltori, MD, michela.saltori@apss.tn.it
OSPEDALE CA' FONCELLO - UOC Cardiologia
Treviso
Nicola Gasparetto, MD, nicola.gasparetto@aulss2.veneto.it
Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic
Vimercate
Antonio Cirò, MD, antonio.ciro@asst-brianza.it
About this study
Official title: 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.
Read the detailed description
Despite major improvements in the acute management of Acute Coronary Syndromes (ACS), recurrent cardiovascular events remain frequent after hospital discharge. Real-world registries consistently show suboptimal implementation of guideline-recommended lipid-lowering strategies, with more than 60% of patients failing to achieve recommended LDL-cholesterol (LDL-c) targets after ACS. Early and intensive LDL-c reduction is associated with improved short-term and long-term outcomes. While injectable lipid-lowering therapies such as PCSK9 inhibitors have demonstrated rapid LDL-c reduction when initiated early after ACS, their high cost and parenteral administration limit widespread adoption. 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.
- Conditions
- Acute Coronary Syndromes, Secondary Prevention, Lipids
- Being tested
- Triple oral lipid lowering treatment
- Keywords
- ACS, Lipid-lowering therapy, atherothrombotic coronary event, secondary prevention, triple oral lipid lowering therapy
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple oral lipid lowering treatmentDrug
Triple oral lipid lowering treatment including high intensity statin, ezetimibe and bembedoic acid
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual Care |
| High intensity statin plus ezetimibe plus bempedoic acid | Experimental | patients will receive a triple oral lipid lowering therapy including a high intensity statin, ezetimibe and bempedoic acid Receives: Drug: Triple oral lipid lowering treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (7)
Percentage of patients with LDL-c level <70 mg/dL
Difference in percentage of patients with LDL-c level <70 mg/dL at 8 weeks
Measured: 8 weeks
Percentage of patients with LDL-c level <55 mg/dL
Difference in percentage of patients with LDL-c level <55 mg/dL at 8 weeks
Measured: 8 weeks
Percentage of patients with LDL-c level <40 mg/dL in those with a recurrent ACS event in the previous 48 months
Difference in percentage of patients with LDL-c level <40 mg/dL at 8 weeks in those with a recurrent ACS event in the previous 48 months
Measured: 8 weeks
Change in high-sensitivity CRP (hs-CRP)
Change in high-sensitivity CRP (hs-CRP) at 8 weeks
Measured: 8 weeks
Persistence of active treatment and discontinuation rate
Rate of persistence of active treatment and discontinuation rate of allocated treatment
Measured: 8 weeks
Rate of adverse events
Safety of the investigational study drug by adverse event recording
Measured: 8 weeks
Rate of adverse events
Safety of the investigational study drug by adverse event recording
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Care Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Responsible party
- Sponsor
- Investigators
- Furio Colivicchi, MD, Study chair, San Filippo neri Hospital - RomeAldo P Maggioni, MD, Study chair, Fondazione per il Tuo cuorePietro Scicchitano, MD, Study chair, Ospedale Miulli - Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440381
- Sponsor's protocol ID
- G114
- Acronym
- PERSUADE
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE (PERSUADE) Trial
- ClinicalTrials.gov ID
- NCT07440381
- Acronym / sponsor ID
- PERSUADE / G114
- Conditions
- Acute Coronary Syndromes, Secondary Prevention, Lipids
- Keywords
- ACS, Lipid-lowering therapy, atherothrombotic coronary event, secondary prevention, triple oral lipid lowering therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Heart Care FoundationUniversity, hospital or other
- Collaborators
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite major improvements in the acute management of Acute Coronary Syndromes (ACS), recurrent cardiovascular events remain frequent after hospital discharge. Real-world registries consistently show suboptimal implementation of guideline-recommended lipid-lowering strategies, with more than 60% of patients failing to achieve recommended LDL-cholesterol (LDL-c) targets after ACS. Early and intensive LDL-c reduction is associated with improved short-term and long-term outcomes. While injectable lipid-lowering therapies such as PCSK9 inhibitors have demonstrated rapid LDL-c reduction when initiated early after ACS, their high cost and parenteral administration limit widespread adoption. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual Care |
| High intensity statin plus ezetimibe plus bempedoic acid | Experimental | Drug: Triple oral lipid lowering treatmentpatients will receive a triple oral lipid lowering therapy including a high intensity statin, ezetimibe and bempedoic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple oral lipid lowering treatmentTriple oral lipid lowering treatment including high intensity statin, ezetimibe and bembedoic acid | Drug | High intensity statin plus ezetimibe plus bempedoic acid |
Primary outcome
Mean percent change in LDL-c levels
Time frame: 8 weeks
the difference in the mean percent change in LDL-c levels from baseline at 8 weeks between triple combo therapy and usual care.
7 secondary outcomes
Percentage of patients with LDL-c level <70 mg/dL
Time frame: 8 weeks
Percentage of patients with LDL-c level <55 mg/dL
Time frame: 8 weeks
Percentage of patients with LDL-c level <40 mg/dL in those with a recurrent ACS event in the previous 48 months
Time frame: 8 weeks
Change in high-sensitivity CRP (hs-CRP)
Time frame: 8 weeks
Persistence of active treatment and discontinuation rate
Time frame: 8 weeks
Rate of adverse events
Time frame: 8 weeks
Rate of adverse events
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Furio Colivicchi, MD study chair
San Filippo neri Hospital - Rome
Aldo P Maggioni, MD study chair
Fondazione per il Tuo cuore
Pietro Scicchitano, MD study chair
Ospedale Miulli - Bari
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triple oral lipid lowering treatment in people with Acute Coronary Syndromes and Secondary Prevention, run by Heart Care Foundation at 35 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Orso, MD (+390555101230, persuade@heartcarefoundation.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean percent change in LDL-c levels (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.