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临床试验/NCT07839741
NCT07839741招募中4 期

Low-density Lipoprotein Cholesterol Reduction Following Ezetimibe Initiation: Patterns of Treatment Response

Universidade do Porto1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
100
试验地点
1
主要终点
Percentage change in LDL-C following ezetimibe initiation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Ezetimibe treatment

Experimental

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.

干预措施: Ezetimibe (Drug)

结局指标

主要结局

Percentage change in LDL-C following ezetimibe initiation

时间窗: 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 (%).

次要结局

  • Percentage change in non-HDL-C following ezetimibe initiation(At least 8 weeks after ezetimibe initiation.)
  • Percentage change in apolipoprotein B (ApoB) following ezetimibe initiation(At least 8 weeks after ezetimibe initiation.)
  • Association between baseline 24-hour urinary sodium excretion and percentage change in LDL-C following ezetimibe initiation(At least 8 weeks after ezetimibe initiation.)
  • Proportion of participants achieving a clinically meaningful change in LDL-C following ezetimibe initiation(At least 8 weeks after ezetimibe initiation.)
  • Performance of a multivariable prediction model for LDL-C response following ezetimibe initiation(At least 8 weeks after ezetimibe initiation.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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