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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Vesicle

• Study Type: Observational
• Enrollment (Actual): 93

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients on low-dose aspirin treatment for cardiovascular prevention (enteric coated, Cardio aspirin 100 mg/die Bayer, Milan, Italy) once daily (o.d.) for at least 1 month

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
84 patients on ASA chronic treatment; 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; 9 healthy subjects, not on ASA treatment, as controls.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: G. d'Annunzio University

Study record dates

Study Major Dates

• Study Start: September 21, 2015
• Primary Completion (Actual): May 9, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: aspirin; circulating extracellular vesicles
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: EvASA