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CompletedNCT05584943Updated Oct 18, 2022

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

An observational study in Cardiovascular Diseases and Vesicle, sponsored by G. d'Annunzio University. Completed. Per ClinicalTrials.gov, last updated 2022-10-18.

Sponsored by G. d'Annunzio University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
93
Sex
All
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Study 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.

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Conditions studied

  • Cardiovascular Diseases
  • Vesicle

Keywords

  • circulating extracellular vesicles
  • aspirin
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In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 928 are open to participants now.

This study's enrollment of 93 is below the median of 600 across 1,524 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

G. d'Annunzio University is the lead sponsor of 65 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
93 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1st - 12th month

  2. 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

    Time frame: 13th - 24th month

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Study locations

No study locations are listed for this record.

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2015, a primary completion of May 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2022
First posted
Oct 18, 2022
Start
Sep 21, 2015
Primary completionActual
May 9, 2017
CompletionActual
Dec 31, 2017
Last update
Oct 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05584943
Lead sponsor
G. d'Annunzio University
Responsible party
Francesca Santilli (Associate Professor of Internal Medicine, Department of Medicine and Aging, Head of Thrombosis and Hemostasis Unit, G. d'Annunzio University) — Principal investigator
First posted
Oct 18, 2022
Start date
Sep 21, 2015
Primary completion
May 9, 2017
Completion
Dec 31, 2017
Last update
Oct 18, 2022

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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