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

Completed

• Conditions: Cardiovascular Diseases; Vesicle

• Registration Number: NCT05584943
• Lead Sponsor: G. d'Annunzio University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-21
• Primary Completion: 2017-05-09
• Study Completion: 2017-12-31
• Status Verified: 2022-10
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-14
• Last Update Submitted: 2022-10-14
• Study First Posted: 2022-10-18
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kinetics of circulating extracellular vesicles after low-dose aspirin administration	1st - 12th month	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
Aspirin response and circulating extracellular vesicles over the 24-hour	13th - 24th month	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