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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05584943

Enrollment

Registered

2022-10-18

Start date

2015-09-21

Completion date

2017-12-31

Last updated

2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Vesicle

Keywords

circulating extracellular vesicles, aspirin

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results