Early LDL -cholesterol reduction in patients with acute coronary syndrome: a randomized clinical trial
Key facts
- Where
- Naples és Turin, OlaszországSee the 2 sites
- Phase
- 4. fázis
Where in Olaszország
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, OlaszországToborzás még nem indult
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Trial code
- EU 2026-527896-27-00
- Record updated
- 2026. november 9.
- Original description
The primary objective is to evaluate the early efficacy at 6-week of a lipid-lowering therapy in ACS patients using a treat-to-target strategy, which accounts for baseline LDL-C levels, in comparison to a default strategy, which is based on 2023 ESC guidelines recommendations on ACS as well as the 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidemias.Read full original descriptionShow less
The primary objective is to evaluate the early efficacy at 6-week of a lipid-lowering therapy in ACS patients using a treat-to-target strategy, which accounts for baseline LDL-C levels, in comparison to a default strategy, which is based on 2023 ESC guidelines recommendations on ACS as well as the 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidemias.
Inclusion: Male or female patients aged equal or greater than 18 years; Diagnosis of ST-elevation or non-ST-elevation ACS; Baseline LDL-C ≥55 mg/dL [≥1.4 mmol/L] for a first ACS event or LDL-C ≥40 mg/dL [≥1.0 mmol/L] for a recurrent ischemic event.
Exclusion: Absolute or relative contraindication to any component of lipid-lowering therapy (i.e., high-dose statin, ezetimibe, PCSK9 inhibitor [evolocumab, alirocumab, inclisiran], bempedoic acid), including known hypersensitivity to the active substance or to any of the excipients of these medicinal products. Contraindications will be assessed according to the applicable Summary of Product Characteristics (SmPC) and will explicitly include the following: concomitant use of bempedoic acid with simvastatin at doses >40 mg/day; concomitant use of atorvastatin with glecaprevir/pibrentasvir; use of rosuvastatin in patients with myopathy or receiving concomitant cyclosporine; use of rosuvastatin 40 mg/day in patients with predisposing factors for myopathy/rhabdomyolysis, as specified in the applicable SmPC; Treatment with systemic steroids or systemic cyclosporine in the past 3 months; Patients already on PCSK9 inhibitor; Participation in a clinical trial in which an investigational drug was administered within 30 days before screening or within five elimination half-lives of the previously administered investigational drug, whichever period is longer; Patient who received cholesterol ester transfer protein inhibitors in the past 12 months prior to screening; Active liver disease or history hepatic dysfunction or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 3-fold the URL; Limited life expectancy (less than 1-year) as judged by the treating physician; Pregnant or breastfeeding women, or women of childbearing potential not willing to use highly effective contraception during the study period; Limited life expectancy (less than 1-year) as judged by the treating physician; Patients already on highest tolerated statin and ezetimibe; Unstable clinical status (hemodynamic or electrical instability); Severe renal dysfunction, defined by estimated glomerular filtration rate <30 ml/min/1.73 m^2.