Cardiovascular DiseasesNCT05584943
Kinetics of cEVs Over the 24-hour Dosing Interval After Low-dose Aspirin Administration
An observational study of Cardiovascular Diseases and Vesicle, run by G. d'Annunzio University.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Vesicle
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2015to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
About this study
Official title: Kinetics of Circulating Extracellular Vesicles Over the 24-hour Dosing Interval After Low-dose Aspirin Administration in Patients at Cardiovascular Risk
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.
- Conditions
- Cardiovascular Diseases, Vesicle
- Keywords
- circulating extracellular vesicles, aspirin
- Medical subject headings
- Cardiovascular Diseases, Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1st - 12th month
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
Measured: 13th - 24th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start21 Sep 2015
- Primary completion9 May 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Santilli, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584943
- Sponsor's protocol ID
- EvASA
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Circulating Extracellular Vesicles Over the 24-hour Dosing Interval After Low-dose Aspirin Administration in Patients at Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT05584943
- Acronym / sponsor ID
- EvASA
- Conditions
- Cardiovascular Diseases, Vesicle
- Keywords
- circulating extracellular vesicles, aspirin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 21 Sep 2015
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- cigarette smoking insufficiency
- clinically significant hepatic insufficiency
- clinically significant renal insufficiency
- clinically significant cardiac insufficiency
- clinically significant pulmonary insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Vesicle, run by G. d'Annunzio University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetics of circulating extracellular vesicles after low-dose aspirin administration (time frame: 1st - 12th month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.