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

April 2, 2025 updated by: Centro Cardiologico Monzino

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Study participants will be recruited among patients admitted to the Cardiology Units of the Centro Cardiologico Monzino IRCCS

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of 5-follow-up

Collaborators and Investigators

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

Sponsor

Centro Cardiologico Monzino

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)

May 1, 2012

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1436/21-CCM 1508

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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