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Completed

NCT Number: NCT05584943

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

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.

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Key information

Conditions

Cardiovascular Diseases Blister Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases Vesicle

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Kinetics of circulating extracellular vesicles after low-dose aspirin administration

    Time frame: 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

  2. Aspirin response and circulating extracellular vesicles over the 24-hour

    Time frame: 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

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 18, 2022
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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