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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Change in LDL cholesterol level [Time frame: Baseline to 3 months]

Secondary outcome measures (1)

• Incidence of adverse drug reactions [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Punjab Institute of Cardiology — Lahore

Publications

• Raposeiras-Roubin S, Abu Assi E, Jimenez Mendez C, Minguez de la Guia E, Perez Rivera JA, Marcos Mangas M, Ayesta A, Uribarri A, Jorge Perez P, Antunez Muinos PJ, Bonanad Lozano C, Carrasquer A, Viana-Tejedor A, Dominguez Erquicia P, Villar Ruiz A, Lopez Vazquez M, Aguilar Iglesias L, Alen Andremar A, Vidal Burdeus M, Martin Cabeza MM, Gonzalez Cambeiro MC, Bompart D, Gomez Polo JC, Garcia Garcia PMID 41200807

Identifiers

NCT: NCT07508254 · RTPGME-Research-419

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗