Kinetics of cEVs Over the 24-hour Dosing Interval After Low-dose Aspirin Administration

Study Overview
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Brief Summary
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Extracellular vesicles (EVs) are small vesicles deriving from all cell types during cell activation, involved in transcellular communication, and regarded as predictors of vascular damage and of cardiovascular events. The investigators will test the hypothesis that, in patients on chronic low-dose aspirin treatment for cardiovascular prevention, aspirin may affect the release of EVs within the 24 hours interval.

Official Title
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Kinetics of Circulating Extracellular Vesicles Over the 24-hour Dosing Interval After Low-dose Aspirin Administration in Patients at Cardiovascular Risk

Conditions
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Cardiovascular Diseases, Vesicle

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients on low-dose aspirin treatment for cardiovascular prevention for at least 1 month arterial hypertension if well controlled with stable drug therapy hypercholesterolemia if well controlled with stable drug therapy Exclusion Criteria: cigarette smoking insufficiency clinically significant hepatic insufficiency clinically significant renal insufficiency clinically significant cardiac insufficiency clinically significant pulmonary insufficiency history of malignant neoplasms (diagnosed and treated within the past 5 years) pregnancy or lactation history of malabsorption regular (daily) alcohol consumption regular (i.e., more than 3 days per week) non steroidal anti-inflammatory drug intake type 1 diabetes excluded by islet autoantibodies evaluation (anti-glutamic acid decarboxylase, islet cell cytoplasmic, and IA-2 antibodies), family history of type 1 diabetes, age lower than 40 years, lean phenotype, early requirement for insulin therapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 84 patients on ASA chronic treatment<br>A total of 84 patients on chronic treatment with low-dose ASA (enteric coated, Cardio aspirin 100 mg/die Bayer, Milan, Italy) once daily (o.d.) for at least 1 month | |
| Healthy subject<br>9 healthy subjects, not on ASA treatment, as controls. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetics of circulating extracellular vesicles after low-dose aspirin administration | In patients receiving low-dose aspirin for cardiovascular prevention, evaluate the potential effects of chronic aspirin treatment on circulating extracellular vesicles levels over the 24-hour interval | 1st - 12th month | 
| Aspirin response and circulating extracellular vesicles over the 24-hour | In patients receiving low-dose aspirin for cardiovascular prevention, evaluate the role of circulating extracellular vesicles as a potential determinant of interindividual variability in the aspirin response | 13th - 24th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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circulating extracellular vesicles, aspirin