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| Name | Class |
|---|---|
| Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triple oral lipid lowering treatment | Drug | Triple oral lipid lowering treatment including high intensity statin, ezetimibe and bembedoic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Orso, MD | Contact | +390555101230 | persuade@heartcarefoundation.it |
| Name | Affiliation | Role |
|---|---|---|
| Furio Colivicchi, MD | San Filippo neri Hospital - Rome | Study Chair |
| Aldo P Maggioni, MD | Fondazione per il Tuo cuore | Study Chair |
| Pietro Scicchitano, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Miulli - U.O.C. CARDIOLOGIA - UTIC | Acquaviva delle Fonti | Italy |
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| 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 | 8 weeks |
| Change in high-sensitivity CRP (hs-CRP) | Change in high-sensitivity CRP (hs-CRP) at 8 weeks | 8 weeks |
| Persistence of active treatment and discontinuation rate | Rate of persistence of active treatment and discontinuation rate of allocated treatment | 8 weeks |
| Rate of adverse events | Safety of the investigational study drug by adverse event recording | 8 weeks |
| Rate of adverse events | Safety of the investigational study drug by adverse event recording | 3 months |
| Ospedale Miulli - Bari |
| Study Chair |
| 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 |
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| 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 |
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| Aou Policlinico P. Giaccone - U.O.C. Cardiologia | Palermo | Italy |
|
| Arnas P.O. Civico E Benfratelli - Uoc Utic | Palermo | Italy |
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| FONDAZIONE IRCCS POLICLINICO SAN MATTEO - UOC Cardiologia | Pavia | Italy |
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| 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 |
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| OSPEDALE SANTA CHIARA - Divisione di Cardiologia | Trento | Italy |
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| OSPEDALE CA' FONCELLO - UOC Cardiologia | Treviso | Italy |
|
| Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic | Vimercate | Italy |
|
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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