LDL Cholesterol Reduction Following Ezetimibe Initiation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversidade do Porto
About this trial
This clinical trial will study why some people have a larger drop in low-density lipoprotein cholesterol (LDL-C), known as "bad cholesterol," after starting ezetimibe. Ezetimibe is a medicine used to lower cholesterol when current treatment is not enough. Adults aged 18 to 75 years who need additional cholesterol treatment will take ezetimibe, either alone or added to their usual stable medication. Researchers will examine whether diet, salt intake, physical activity, and personal health factors influence how much LDL-C levels fall after treatment. Participants will have blood tests before and after starting ezetimibe, complete diet and activity questionnaires, and provide a 24-hour urine sample. The goal is to help doctors better understand who benefits most from ezetimibe and improve personalized cholesterol treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 and ≤75 years at the time of ezetimibe initiation;
Initiation of ezetimibe as monotherapy or, in patients already treated with statins or other LDL-C-lowering agents, provided that neither the compound nor the dose of the concomitant LDL-C-lowering therapy was modified at the time of ezetimibe initiation.
Disqualifiers
Absence of indication for ezetimibe therapy as determined by the treating physician;
Initiation of ezetimibe with concomitant modification of statin or other LDL-C-lowering medication type or dosage;
Initiation of ezetimibe/statin combination therapy as the first lipid-lowering regimen.
Trial design
Design model
Single group
Treatments tested in this trial
Ezetimibe
DrugEzetimibe will be initiated at the approved standard dose of 10 mg once daily, either as monotherapy or added to stable background lipid-lowering therapy (e.g., statins) without modification of concomitant drug type or dosage at the time of initiation. Treatment will be prescribed according to routine clinical practice and guideline-based indications. Lipid profile and clinical parameters will be assessed before and after ezetimibe initiation to evaluate treatment response.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Ezetimibe treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage change in LDL-C following ezetimibe initiation
Percentage change in LDL-C following ezetimibe initiation, calculated as \[(follow-up LDL-C - baseline LDL-C) / baseline LDL-C\] × 100 and expressed as a percentage (%).
Time frame
At least 8 weeks after ezetimibe initiation.Secondary outcomes
1
Percentage change in non-HDL-C following ezetimibe initiation
Percentage change in non-HDL-C following ezetimibe initiation, calculated as \[(follow-up non-HDL-C - baseline non-HDL-C) / baseline non-HDL-C\] × 100 and expressed as a percentage (%).
Time frame
At least 8 weeks after ezetimibe initiation.2
Percentage change in apolipoprotein B (ApoB) following ezetimibe initiation
Percentage change in ApoB following ezetimibe initiation, calculated as \[(follow-up ApoB - baseline ApoB) / baseline ApoB\] × 100 and expressed as a percentage (%).
Time frame
At least 8 weeks after ezetimibe initiation.3
Association between baseline 24-hour urinary sodium excretion and percentage change in LDL-C following ezetimibe initiation
The association between baseline 24-hour urinary sodium excretion and percentage change in LDL-C following ezetimibe initiation will be evaluated using Spearman's rank correlation analysis. The outcome measure will be the Spearman correlation coefficient (ρ), which ranges from -1 to +1.
Time frame
At least 8 weeks after ezetimibe initiation.4
Proportion of participants achieving a clinically meaningful change in LDL-C following ezetimibe initiation
Proportion of participants achieving a clinically meaningful LDL-C response, defined as at least a 20% decrease in LDL-C in participants treated with ezetimibe as monotherapy, or at least a 10% additional decrease in LDL-C when ezetimibe is added to high-intensity baseline statin therapy.
Time frame
At least 8 weeks after ezetimibe initiation.Sponsors and contacts
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Source ClinicalTrials.gov