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

G. d'Annunzio University

Status: Completed

Conditions: Vesicle; Cardiovascular Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT05584943

EvASA

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

93 participants in 2 patient groups

84 patients on ASA chronic treatment

Description:

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

Description:

9 healthy subjects, not on ASA treatment, as controls.