LDL Cholesterol Reduction Following Ezetimibe Initiation (EZE-TRACK)

September 23, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Portugal
      • Porto, Portugal, 4200-319
        • Recruiting
        • Unidade Local de Saúde São João
        • Contact:
        • Principal Investigator:
          • Pedro M. Marques, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage change in LDL-C following ezetimibe initiation
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage change in non-HDL-C following ezetimibe initiation
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade do Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EZE-TRACK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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