triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE

Korábbi kezelés

• 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,

Más betegség

• 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

Laborértékek

• 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),

Egyéb

• 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.

• 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.