Clinical trial NCT06919731: PLATELET TISSUE FACTOR AS BIOMARKER OF THROMBOTIC RISK IN CORONARY ARTERY DISEASE PATIENTS (TRIT-ONE)
Official title: PLATELET-ASSOCIATED TISSUE FACTOR AS A NEW BIOMARKER FOR THROMBOTIC RISK STRATIFICATION IN PATIENTS WITH CORONARY ARTERY DISEASE.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Platelet
Tissue Factor
Biomarker
coronary artery diseases
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study participants will be recruited among patients admitted to the Cardiology Units of the Centro Cardiologico Monzino IRCCS

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality and cardiovascular death
timeFrame: From enrollment to the end of 5-follow-up
Secondary outcomes:
Other outcomes:
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