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Completed

NCT Number: NCT06919731

PLATELET TISSUE FACTOR AS BIOMARKER OF THROMBOTIC RISK IN CORONARY ARTERY DISEASE PATIENTS (TRIT-ONE)

Enhancing thrombotic risk stratification in patients with coronary artery disease (CAD) is crucial for the prevention and management of cardiovascular disease. Existing risk scores, which predict mortality risk and/or the likelihood of adverse cardiovascular events, are based on clinical and laboratory parameters. However, none of these scores incorporates the elevated platelet activation observed in CAD, a critical factor influencing disease progression.

Over the past two decades, research has consistently shown that activated platelets play a pivotal role in plaque formation. These platelets, together with fibrin, form the primary components of thrombi that obstruct coronary arteries, making them central to the pathogenesis of coronary syndromes. Published studies have highlighted how platelet activation triggers the expression of Tissue Factor (TF), a key glycoprotein involved in blood coagulation and thrombotic complications in atherosclerosis. Notably, in patients with coronary syndrome, platelet TF expression is significantly higher than in healthy individuals. The functional ability of platelet TF to generate thrombin further enhances the pro-thrombotic potential of these platelets, underscoring their critical role in thrombus formation.

The objective of this study is to validate the predictive value of platelet Tissue Factor (TF) for cardiovascular events in a cohort of secondary prevention patients treated with antiplatelet drugs, including clopidogrel, ticagrelor, prasugrel, and/or aspirin. The primary endpoint is the assessment of all-cause mortality and cardiovascular death, over a 5-year follow-up period from admission.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patients of either sex, aged 18 years or older, with a diagnosis of acute or stable coronary syndrome, treated with anti-platelet drugs (aspirin and/or clopidogrel, prasugrel and ticagrelor) as per guidelines

Exclusion criteria

pregnant subjects (self-declared); subjects who have received blood transfusions in the last 30 days; subjects over 89 years of age; subjects with hereditary platelet disorders

Treatment and study plan

whole blood flow cytometry analisys

Other

Evaluation of platelet prothrombotic potential through a flow-cytometry analysis of platelet activation marker expression, including P-selectin, aGPIIbIIIa and TF, as well as platelet-leukocyte aggregate formation.

Primary outcomes

  1. All-cause mortality and cardiovascular death

    Time frame: From enrollment to the end of 5-follow-up

    Assessment of all-cause mortality and cardiovascular death over a 5-year follow-up period from enrollment.

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Registry information

Official study title

PLATELET-ASSOCIATED TISSUE FACTOR AS A NEW BIOMARKER FOR THROMBOTIC RISK STRATIFICATION IN PATIENTS WITH CORONARY ARTERY DISEASE.

Acronym: TRIT-ONE

Important dates

Study start
2012
Primary completion
2018
Study completion
2023
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

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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