NCT07508254

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

Triple (Atorvastatin, Ezetimibe, and Bempedoic Acid) Versus Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Punjab Institute of Cardology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate whether triple lipid-lowering therapy (atorvastatin, ezetimibe, and bempedoic acid) is more effective than dual therapy (atorvastatin and ezetimibe) in reducing LDL cholesterol levels in adults with acute coronary syndrome. It will also assess the safety of the treatment. The main questions it aims to answer are: * Does triple therapy result in greater reduction in LDL-C compared to dual therapy? * What adverse effects occur in participants receiving triple therapy? Researchers will compare triple therapy to dual therapy to determine its effectiveness in lowering LDL-C levels. Participants will: * Receive either dual or triple lipid-lowering therapy for 3 months * Attend regular follow-up visits for clinical assessment and laboratory testing * Undergo lipid profile evaluation at baseline and at the end of the study

Detailed description

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.

Conditions

• Acute Coronary Syndromes (ACS)
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Atorvastatin 40 Mg Oral Tablet	Atorvastatin administered orally once daily as part of lipid-lowering therapy
DRUG	Ezetimibe 10 mg	Ezetimibe administered orally once daily to reduce cholesterol absorption
DRUG	Bempedoic Acid 180 MG Oral Tablet	Bempedoic acid administered orally once daily as an adjunct lipid-lowering agent

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-10-01
• Completion: 2026-10-31
• First posted: 2026-04-02
• Last updated: 2026-04-09

Locations

1 site across 1 country: Pakistan