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

NCT ID: NCT05584943

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-21

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Cardiovascular Diseases Vesicle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Healthy subject

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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Francesca Santilli

Associate Professor of Internal Medicine, Department of Medicine and Aging, Head of Thrombosis and Hemostasis Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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EvASA

Identifier Type: -

Identifier Source: org_study_id

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