LDL Cholesterol Reduction Following Ezetimibe Initiation

NCT07839741 | Recruiting Phase 4

• 1 other identifier: EZE-TRACK
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD); Cardiovascular Risk; LDL Cholesterol

Keywords

Ezetimibe; LDL target; EZE-TRACK

Outcome Measures

Primary Outcomes (1)

• 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 (%).

  At least 8 weeks after ezetimibe initiation.

Secondary Outcomes (5)

• 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.

Study Arms (1)

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.

Drug: Ezetimibe

Interventions

Ezetimibe DRUG

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.

Ezetimibe treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Unidade Local de Saúde São João

Porto, 4200-319, Portugal

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Pedro Marques, MD.

CONTACT

(+351) 220426820; pmmarques@med.up.pt

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: September 24, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

PT (1)