A Phase 4 interventional study of Ezetimibe in Atherosclerotic Cardiovascular Disease (ASCVD), Cardiovascular Risk and LDL Cholesterol, sponsored by Universidade do Porto. Recruiting at 1 site in Portugal. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Universidade do Porto · Phase 4, Interventional, and Treatment
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.
Reduction of low-density lipoprotein cholesterol (LDL-C) is a central strategy for cardiovascular risk reduction. Although ezetimibe provides additional LDL-C lowering when added to background therapy, substantial interindividual variability in treatment response has been observed. Determinants of this variability, particularly modifiable lifestyle factors, remain insufficiently defined. This prospective, single-centre, open-label, pragmatic interventional study is conducted in routine clinical practice to identify baseline clinical and lifestyle predictors of lipid response following ezetimibe initiation. Adults with a clinical indication for ezetimibe will initiate treatment at the approved standard dose, either as monotherapy or added to stable background lipid-lowering therapy. Baseline assessments will include demographic and clinical characteristics, comorbidities, concomitant medications, and laboratory parameters. Dietary intake will be assessed using a validated food frequency questionnaire and objective 24-hour urinary measurements of sodium, potassium, and urea. Physical activity will be evaluated using a validated questionnaire. Lipid parameters will be reassessed after treatment initiation to determine percentage change in LDL-C, non-high-density lipoprotein cholesterol, and apolipoprotein B. Multivariable regression analyses will be performed to identify independent predictors of lipid response. The results may inform personalized lipid-lowering strategies and improve selection of patients most likely to benefit from ezetimibe therapy in real-world clinical settings.
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 879 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Universidade do Porto is the lead sponsor of 174 studies on the registry; 53 are open to participants now.
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Exclusion criteria:
Participants will initiate ezetimibe therapy according to clinical indication, either as monotherapy or added to stable background lipid-lowering treatment without modification of concomitant drug type or dose. The study will assess lipid response and identify clinical and lifestyle predictors of LDL-C reduction following ezetimibe initiation.
Drug: Ezetimibe
Ezetimibe 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.
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.
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.
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.
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.
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.
Performance of a multivariable prediction model for LDL-C response following ezetimibe initiation
Performance of a multivariable prediction model developed to predict the percentage change in LDL-C following ezetimibe initiation. Model performance will be evaluated using discrimination (C-statistic / area under the ROC curve, range 0.5-1.0; higher values indicate better discrimination), calibration (calibration slope and calibration-in-the-large / intercept), and predictive accuracy (Brier score, range 0-1; lower values indicate better accuracy).
Time frame: At least 8 weeks after ezetimibe initiation.
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Studies of the drug tested here: Ezetimibe