A Phase 4 interventional study of Atorvastatin 40 Mg Oral Tablet and Ezetimibe 10 mg in Acute Coronary Syndromes (ACS) and Hypercholesterolemia, sponsored by Punjab Institute of Cardology. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Punjab Institute of Cardology · Phase 4, Interventional, and Treatment
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:
Researchers will compare triple therapy to dual therapy to determine its effectiveness in lowering LDL-C levels.
Participants will:
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.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 120 is below the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →This is the only study on the registry with Punjab Institute of Cardology as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Atorvastatin administered orally once daily as part of lipid-lowering therapy
Ezetimibe administered orally once daily to reduce cholesterol absorption
Bempedoic acid administered orally once daily as an adjunct lipid-lowering agent
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.
Time frame: Baseline to 3 months
Incidence of adverse drug reactions
Number of participants experiencing adverse drug reactions during the study period.
Time frame: 3 months
Plan to share: No — Individual participant data (IPD) will not be shared.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Atorvastatin · Ezetimibe