Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

LDL Cholesterol Reduction Following Ezetimibe Initiation (EZE-TRACK)

23. september 2026 opdateret af: Universidade do Porto

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Portugal
      • Porto, Portugal, 4200-319
        • Rekruttering
        • Unidade Local de Saúde São João
        • Kontakt:
        • Ledende efterforsker:
          • Pedro M. Marques, MD.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage change in LDL-C following ezetimibe initiation
Tidsramme: At least 8 weeks after 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 (%).
At least 8 weeks after ezetimibe initiation.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage change in non-HDL-C following ezetimibe initiation
Tidsramme: At least 8 weeks after 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 (%).
At least 8 weeks after ezetimibe initiation.
Percentage change in apolipoprotein B (ApoB) following ezetimibe initiation
Tidsramme: At least 8 weeks after ezetimibe initiation.

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.
Association between baseline 24-hour urinary sodium excretion and percentage change in LDL-C following ezetimibe initiation
Tidsramme: At least 8 weeks after 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.
At least 8 weeks after ezetimibe initiation.
Proportion of participants achieving a clinically meaningful change in LDL-C following ezetimibe initiation
Tidsramme: At least 8 weeks after 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.
At least 8 weeks after ezetimibe initiation.
Performance of a multivariable prediction model for LDL-C response following ezetimibe initiation
Tidsramme: At least 8 weeks after 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).
At least 8 weeks after ezetimibe initiation.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidade do Porto

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2025

Primær færdiggørelse (Anslået)

1. januar 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

13. april 2026

Først indsendt, der opfyldte QC-kriterier

23. september 2026

Først opslået (Faktiske)

24. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EZE-TRACK

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner