Acute Coronary Syndromes (ACS)Phase 4TLD-ACSNCT07508254
Triple vs Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome
A Phase 4 study testing Atorvastatin 40 Mg Oral Tablet, Ezetimibe 10 mg and Bempedoic Acid 180 MG Oral Tablet in people with Acute Coronary Syndromes (ACS) and Hypercholesterolemia, run by Punjab Institute of Cardology at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes (ACS), Hypercholesterolemia
- What is being tested?
- Atorvastatin 40 Mg Oral Tablet, Ezetimibe 10 mg and Bempedoic Acid 180 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 31 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Punjab Institute of Cardiology
Lahore, Punjab Province, 56000
Usman Sajid, MBBS, +923028169194, thextremefire@gmail.com
Usman Sajid, MBBS
About this study
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
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:
Read more
- 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
Read the 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.
- Being tested
- Atorvastatin 40 Mg Oral Tablet, Ezetimibe 10 mg, Bempedoic Acid 180 MG Oral Tablet
- Keywords
- LDL-C Reduction, Statins, Ezetimibe, Bempedoic Acid, Randomized Controlled Trial, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 40 Mg Oral TabletDrug
Atorvastatin administered orally once daily as part of lipid-lowering therapy
Ezetimibe 10 mgDrug
Ezetimibe administered orally once daily to reduce cholesterol absorption
Bempedoic Acid 180 MG Oral TabletDrug
Bempedoic acid administered orally once daily as an adjunct lipid-lowering agent
| Study group | Role | What they receive |
|---|---|---|
| Dual Therapy Group | Experimental | Participants will receive dual lipid-lowering therapy consisting of atorvastatin and ezetimibe for a duration of 6 weeks. Receives: 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. Receives: Drug: Atorvastatin 40 Mg Oral Tablet; Drug: Ezetimibe 10 mg; Drug: Bempedoic Acid 180 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months
Secondary outcomes (1)
Incidence of adverse drug reactions
Number of participants experiencing adverse drug reactions during the study period.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Punjab Institute of Cardology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usman Sajid, Punjab Institute of Cardology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508254
- Sponsor's protocol ID
- RTPGME-Research-419
- Acronym
- TLD-ACS
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
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 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.
PubMed 41200807
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07508254
- Acronym / sponsor ID
- TLD-ACS / RTPGME-Research-419
- Keywords
- LDL-C Reduction, Statins, Ezetimibe, Bempedoic Acid, Randomized Controlled Trial, Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Punjab Institute of CardologyUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Dual Therapy Group | Experimental | Drug: Atorvastatin 40 Mg Oral Tablet, Drug: Ezetimibe 10 mgParticipants will receive dual lipid-lowering therapy consisting of atorvastatin and ezetimibe for a duration of 6 weeks. |
| Triple Therapy Group | Experimental | Drug: Atorvastatin 40 Mg Oral Tablet, Drug: Ezetimibe 10 mg, Drug: Bempedoic Acid 180 MG Oral TabletParticipants will receive triple lipid-lowering therapy consisting of atorvastatin, ezetimibe, and bempedoic acid for a duration of 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 40 Mg Oral TabletAtorvastatin administered orally once daily as part of lipid-lowering therapy | Drug | Dual Therapy Group, Triple Therapy Group |
| Ezetimibe 10 mgEzetimibe administered orally once daily to reduce cholesterol absorption | Drug | Dual Therapy Group, Triple Therapy Group |
| Bempedoic Acid 180 MG Oral TabletBempedoic acid administered orally once daily as an adjunct lipid-lowering agent | Drug | Triple Therapy Group |
Primary outcome
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.
1 secondary outcome
Incidence of adverse drug reactions
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 41200807Raposeiras-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.
- This landmark trial showed that adding ezetimibe to statin further lowers LDL and improves cardiovascular outcomesLink provided by the sponsor.
- This trial showed that adding Bempidoic acid to statin therapy further lowers LDL and improves cardiovascular outcomesLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin 40 Mg Oral Tablet, Ezetimibe 10 mg and Bempedoic Acid 180 MG Oral Tablet in people with Acute Coronary Syndromes (ACS) and Hypercholesterolemia, run by Punjab Institute of Cardology at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Usman Sajid, MBBS, Resident cardiologist (+923028169194, thextremefire@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL cholesterol level (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07508254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.