Triple vs Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome (TLD-ACS)

April 3, 2026 updated by: Usman Sajid, Punjab Institute of Cardology

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 56000
        • Punjab Institute of Cardiology
        • Contact:
        • Principal Investigator:
          • Usman Sajid, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dual Therapy Group
Participants will receive dual lipid-lowering therapy consisting of atorvastatin and ezetimibe for a duration of 6 weeks.
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
Experimental: Triple Therapy Group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LDL cholesterol level
Time Frame: Baseline to 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse drug reactions
Time Frame: 3 months
Number of participants experiencing adverse drug reactions during the study period.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Punjab Institute of Cardology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTPGME-Research-419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypercholesterolemia

Clinical Trials on Atorvastatin 40 Mg Oral Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe