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

ConditionsAcute Coronary Syndromes (ACS)Hypercholesterolemia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPunjab Institute of Cardology

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atorvastatin 40 Mg Oral Tablet

    Drug

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

  • Ezetimibe 10 mg

    Drug

    Ezetimibe administered orally once daily to reduce cholesterol absorption

  • Bempedoic Acid 180 MG Oral Tablet

    Drug

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Dual Therapy GroupExperimental treatment 2 interventions
Group B: Triple Therapy GroupExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
Baseline to 3 months

Secondary outcomes

1

Incidence of adverse drug reactions

Number of participants experiencing adverse drug reactions during the study period.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Punjab Institute of Cardology

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: