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

NCT07508254 | Not Yet Recruiting Phase 4

• 1 other identifier: RTPGME-Research-419
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Coronary Syndromes (ACS); Hypercholesterolemia

Keywords

LDL-C Reduction; Statins; Ezetimibe; Bempedoic Acid; Randomized Controlled Trial; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in LDL cholesterol level

  Change in low-density lipoprotein cholesterol (LDL-C) measured in mg/dL from baseline to 3 months after initiation of therapy.

  Baseline to 3 months

Secondary Outcomes (1)

• Incidence of adverse drug reactions

  3 months

Study Arms (2)

Dual Therapy Group

EXPERIMENTAL

Participants will receive dual lipid-lowering therapy consisting of atorvastatin and ezetimibe for a duration of 6 weeks.

Drug: Atorvastatin 40 Mg Oral Tablet; Drug: Ezetimibe 10 mg

Triple Therapy Group

EXPERIMENTAL

Participants will receive triple lipid-lowering therapy consisting of atorvastatin, ezetimibe, and bempedoic acid for a duration of 3 months.

Drug: Atorvastatin 40 Mg Oral Tablet; Drug: Ezetimibe 10 mg; Drug: Bempedoic Acid 180 MG Oral Tablet

Interventions

Bempedoic Acid 180 MG Oral Tablet DRUG

Bempedoic acid administered orally once daily as an adjunct lipid-lowering agent

Triple Therapy Group

Ezetimibe 10 mg DRUG

Ezetimibe administered orally once daily to reduce cholesterol absorption

Dual Therapy Group; Triple Therapy Group

Atorvastatin 40 Mg Oral Tablet DRUG

Atorvastatin administered orally once daily as part of lipid-lowering therapy

Dual Therapy Group; Triple Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Punjab Institute of Cardology: lead

Study Sites (1)

Punjab Institute of Cardiology

Lahore, Punjab Province, 56000, Pakistan

Location

Related Publications (1)

• 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 MT, Merino Merino A, Rozado J, Panera de la Mano JA, Salmeron Martinez F, Sanchez Corral E, Santos Sanchez I, Hernandez-Martos AV, Antelo Abejon A, Iniguez Romo A, Corbi-Pascual M, Ariza-Sole A. Triple Versus Dual Lipid-Lowering Therapy in Acute Coronary Syndrome: The ES-BempedACS Randomized Clinical Trial. Circulation. 2026 Jan 20;153(3):140-149. doi: 10.1161/CIRCULATIONAHA.125.075388. Epub 2025 Nov 7.

  PMID: 41200807 BACKGROUND

Related Links

• This landmark trial showed that adding ezetimibe to statin further lowers LDL and improves cardiovascular outcomes
• This trial showed that adding Bempidoic acid to statin therapy further lowers LDL and improves cardiovascular outcomes

MeSH Terms

Conditions

Acute Coronary Syndrome; Hypercholesterolemia

Interventions

Atorvastatin; Tablets; Ezetimibe; 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations; Azetidines; Azetines

Central Study Contacts

Usman Sajid, MBBS, Resident cardiologist

CONTACT

+923028169194; thextremefire@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study in which both participants and investigators will be aware of the assigned treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either dual lipid-lowering therapy (atorvastatin and ezetimibe) or triple lipid-lowering therapy (atorvastatin, ezetimibe, and bempedoic acid).

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)