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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Triple oral lipid lowering treatment including high intensity statin, ezetimibe and bembedoic acid
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
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.
Time frame: 8 weeks
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
Time frame: 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
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
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
Time frame: 8 weeks
Change in high-sensitivity CRP (hs-CRP)
Change in high-sensitivity CRP (hs-CRP) at 8 weeks
Time frame: 8 weeks
Persistence of active treatment and discontinuation rate
Rate of persistence of active treatment and discontinuation rate of allocated treatment
Time frame: 8 weeks
Rate of adverse events
Safety of the investigational study drug by adverse event recording
Time frame: 8 weeks
Rate of adverse events
Safety of the investigational study drug by adverse event recording
Time frame: 3 months
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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
...and 25 more locations