LDL Cholesterol Reduction Following Ezetimibe Initiation (EZE-TRACK)
Low-density Lipoprotein Cholesterol Reduction Following Ezetimibe Initiation: Patterns of Treatment Response
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Pedro Marques, MD.
- Numero di telefono: (+351) (+351) 220426820
- Email: pmmarques@med.up.pt
Luoghi di studio
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Porto, Portogallo, 4200-319
- Reclutamento
- Unidade Local de Saúde São João
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Contatto:
- Marques M. Pedro, MD.
- Numero di telefono: (+351) (+351) 22 042 68 20
- Email: pmmarques@med.up.pt
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Investigatore principale:
- Pedro M. Marques, MD.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Ezetimibe treatment
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. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage change in LDL-C following ezetimibe initiation
Lasso di tempo: At least 8 weeks after ezetimibe initiation.
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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 (%). |
At least 8 weeks after ezetimibe initiation.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage change in non-HDL-C following ezetimibe initiation
Lasso di tempo: At least 8 weeks after ezetimibe initiation.
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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 (%). |
At least 8 weeks after ezetimibe initiation.
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Percentage change in apolipoprotein B (ApoB) following ezetimibe initiation
Lasso di tempo: At least 8 weeks after ezetimibe initiation.
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Percentage change in ApoB following ezetimibe initiation, calculated as [(follow-up ApoB - baseline ApoB) / baseline ApoB] × 100 and expressed as a percentage (%). |
At least 8 weeks after ezetimibe initiation.
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Association between baseline 24-hour urinary sodium excretion and percentage change in LDL-C following ezetimibe initiation
Lasso di tempo: At least 8 weeks after ezetimibe initiation.
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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. |
At least 8 weeks after ezetimibe initiation.
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Proportion of participants achieving a clinically meaningful change in LDL-C following ezetimibe initiation
Lasso di tempo: At least 8 weeks after ezetimibe initiation.
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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. |
At least 8 weeks after ezetimibe initiation.
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Performance of a multivariable prediction model for LDL-C response following ezetimibe initiation
Lasso di tempo: At least 8 weeks after ezetimibe initiation.
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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). |
At least 8 weeks after ezetimibe initiation.
|
Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EZE-TRACK
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