Triple vs Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome

Acute coronary syndrome (ACS) is a major cause of morbidity and mortality worldwide and is associated with a high risk of recurrent cardiovascular events. Aggressive lipid-lowering therapy, particularly reduction of low-density lipoprotein cholesterol (LDL-C), plays a central role in secondary prevention. Although high-intensity statins are the cornerstone of therapy, many patients fail to achieve target LDL-C levels, necessitating the addition of other lipid-lowering agents.

Ezetimibe, a cholesterol absorption inhibitor, has been shown to further reduce LDL-C levels when combined with statins. Bempedoic acid, a newer lipid-lowering agent that inhibits ATP citrate lyase, offers an additional mechanism to reduce cholesterol synthesis and may provide incremental benefits when added to standard therapy. However, limited evidence exists regarding the combined use of atorvastatin, ezetimibe, and bempedoic acid in patients with ACS.

This randomized controlled trial aims to compare the efficacy and safety of triple lipid-lowering therapy (atorvastatin, ezetimibe, and bempedoic acid) versus dual therapy (atorvastatin and ezetimibe) in patients with ACS. Eligible participants will be randomly assigned in a 1:1 ratio to receive either dual therapy or triple therapy. The intervention period will be three months.

The primary outcome of the study is the change in LDL-C levels from baseline to 3 months. Secondary outcomes include percentage reduction in LDL-C, changes in total cholesterol levels, proportion of patients achieving target LDL-C levels (<70 mg/dL), and incidence of adverse drug reactions.

Participants will undergo baseline clinical evaluation and laboratory investigations, including lipid profile assessment. Follow-up assessments will be conducted during the study period to monitor treatment response and safety. At the end of the study period, lipid levels and clinical outcomes will be reassessed and compared between the two groups.

This study is expected to provide evidence on whether adding bempedoic acid to standard dual lipid-lowering therapy offers superior LDL-C reduction and improved clinical outcomes in patients with ACS.

Inclusion criteria

• Must be older than 18 years, male or female.
• Diagnosis of ACS (Acute Coronary Syndrome) is confirmed when hospitalized.
• Eligible for high-intensity statin therapy (atorvastatin)
• Patients can provide written informed consent.
• Patients will be eager to cooperate with study drugs and follow-up visits.

Exclusion criteria

• Intolerance or hypersensitivity to study drugs.
• Liver or ALT/AST greater than three times the upper normal.
• Renal dysfunction: estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m².
• Gout with frequent bouts or severe hyperuricemia.
• Pregnancy/lactation