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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality and cardiovascular death | 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 |
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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
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Study participants will be recruited among patients admitted to the Cardiology Units of the Centro Cardiologico Monzino IRCCS
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |