Recruiting

NCT Number: NCT07774845

Platelets and Plasma Lipids Relationship as a Biomarker and Potential Therapeutic Target of Thrombogenesis

The objective of this clinical trial is to compare the effect of two different lipid emulsion formulations versus no emulsion on platelet aggregation in individuals without a history of ischemic disease. The hypothesis of this study is:

Platelet aggregation is inversely associated with higher plasma lipid concentrations.

The researchers will compare platelet aggregation in the presence and absence of lipid nanoemulsions in vitro through three pathways using the agonists collagen, adenosine diphosphate, and arachidonic acid. The tests will be performed using light-transmission aggregometry. Various participant parameters, such as lipid profile, will be evaluated to analyze possible correlations with the observed results.

Participants must:

Meet the study's inclusion criteria; Sign the informed consent form; Report to the blood draw laboratory at InCor's AB on the scheduled date and time after fasting for at least 8 hours.

Recruiting

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Key information

Conditions

Cardio Vascular Disease

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Institute, University of São Paulo Medical School (InCor/HCFMUSP)

São Paulo, 05403-900, Brazil

Location status: Recruiting

Location contact

Juliana L. L. F. Regueira, PhD

SUB_INVESTIGATOR

About this study

A prospective case-control study in which the selected volunteers will serve as their own controls.

Participant Selection:

Volunteers with no known atherosclerotic disease will be selected from among employees of InCor/HCFMUSP and, if necessary, from the donor waiting list of the HCFMUSP blood bank.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men and women aged ≥ 40 years.
Willingness to sign the informed consent form.
Absence of known atherosclerotic disease

Exclusion criteria

Use of antiplatelet agents.
Use of anticoagulants.
Use of lipid-lowering agents.
Use of oral hypoglycemic agents or insulin.
Known atherosclerotic disease.
Refusal to sign the informed consent form

Treatment and study plan

Primary outcomes

Effect of Lipid Emulsions on Platelet Aggregation Assessed by Optical Aggregometry

Time frame: Day 1 (single blood sample collection)

Comparison of the effect of different lipid emulsion formulations versus no emulsion (control) on platelet aggregation in blood samples from individuals without a history of ischemic disease.

Study contacts

Contact information is provided by the study sponsor or research team.

José C Nicolau, Senior Professor

CONTACT

[email protected]

11971514117

Juliana L L F Regueira, Postdoctoral Res. Associate

CONTACT

[email protected]

11959564983

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Development and Validation of a New Method to Valuate the Platelet-Plasma Lipid Relationship as a Biomarker and Potential Therapeutic Target of Thrombogenesis

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Aug 19, 2026
Registry last updated: Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting