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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05584943
• Other study ID #: EvASA
• Status: Completed
• Start date: September 21, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2022
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 31, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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