Atherosclerotic Cardiovascular Disease (ASCVD)Phase 4EZE-TRACKNCT07839741
LDL Cholesterol Reduction Following Ezetimibe Initiation
A Phase 4 study testing Ezetimibe in people with Atherosclerotic Cardiovascular Disease (ASCVD) and Cardiovascular Risk, run by Universidade do Porto at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease (ASCVD), Cardiovascular Risk, LDL Cholesterol
- What is being tested?
- Ezetimibe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2025to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saúde São João
Porto, 4200-319
Marques M. Pedro, MD., (+351) 22 042 68 20 ext. (+351), pmmarques@med.up.pt
Pedro M. Marques, MD.
About this study
Official title: 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.
Read the 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.
- Being tested
- Ezetimibe
- Keywords
- Ezetimibe, LDL target, EZE-TRACK
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: At least 8 weeks after ezetimibe initiation.
Secondary outcomes (5)
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 (%).
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At least 8 weeks after ezetimibe initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Jun 2025
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular Disease (ASCVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-centre, open-label, single-arm interventional study. All enrolled 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. There is no randomization or control group. The study is designed to evaluate interindividual variability in lipid response and to identify baseline clinical and lifestyle predictors of percentage LDL-C reduction following ezetimibe initiation.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839741
- Sponsor's protocol ID
- EZE-TRACK
- Acronym
- EZE-TRACK
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-density Lipoprotein Cholesterol Reduction Following Ezetimibe Initiation: Patterns of Treatment Response
- ClinicalTrials.gov ID
- NCT07839741
- Acronym / sponsor ID
- EZE-TRACK / EZE-TRACK
- Keywords
- Ezetimibe, LDL target, EZE-TRACK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-centre, open-label, single-arm interventional study. All enrolled 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. There is no randomization or control group. The study is designed to evaluate interindividual variability in lipid response and to identify baseline clinical and lifestyle predictors of percentage LDL-C reduction following ezetimibe initiation.
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe treatment | Experimental | Drug: EzetimibeParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EzetimibeEzetimibe 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. | Drug | Ezetimibe treatment |
Primary outcome
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 (%).
5 secondary outcomes
Percentage change in non-HDL-C following ezetimibe initiation
Time frame: 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.
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.
Proportion of participants achieving a clinically meaningful change in LDL-C following ezetimibe initiation
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ezetimibe in people with Atherosclerotic Cardiovascular Disease (ASCVD) and Cardiovascular Risk, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro Marques, MD. ((+351) 220426820 ext. (+351), pmmarques@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in LDL-C following ezetimibe initiation (time frame: At least 8 weeks after ezetimibe initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.