Platelet ThrombusEXOPLTNCT06298682
Characterization of Exosomes Platelets-released
An observational study of Platelet Thrombus, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
Extracellular vesicles (EVs) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Thrombus
- How many people
- 175 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jul 2021to 7 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: subjects without known pathologies
Who may be able to join
- subjects without known pathologies
Who cannot join
- individuals with gastrointestinal diseases,
- individuals with history of hepatic diseases,
- individuals with history of urogenital diseases,
- individuals with history of hematological diseases,
- individuals with history of immunological diseases,
- individuals with history of renal diseases,
Show all 14Show fewer
- individuals with history of metabolic diseases
- individuals with history of respiratory diseases
- individuals with history of cancer
- individuals with history of cardiovascular disease
- individuals having permanent organ damage
- individuals with major trauma in the last 6 months prior to enrollment
- individuals with surgery in the last 6 months prior to enrollment
- individuals taking medication in the 15 days prior to enrolment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Daniele Prati
About this study
Extracellular vesicles (EVs) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Platelet-derived EVs (PEVs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. The information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited.
Read the detailed description
This study is a multicentre, observational. We plan to enrol 54 subjects from Centro Cardiologico Monzino IRCCS, and 121 buffy coat related to 121 subjects from Centro Trasfusionale Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. biographical and anthropomorphic data will be recorded, a fasting blood venous sample (from ante-cubital vein) will be collected for the haematochemical analyses and for research samples.
- Conditions
- Platelet Thrombus
- Keywords
- exosomes, platelet activation, platelet inhibitors
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 |
|---|---|---|
| subjects without known pathologies | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis
Measured: 36 month
Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis
Measured: 36 month
Secondary outcomes (1)
Platelet exosome profile emerged by NTA and proteoma analysis will be related with the "biographical" and "anthropometric" data of the subjects.
Measured: 40 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start8 Jul 2021
- Primary completion7 Jul 2026 (estimated)
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet ThrombusStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298682
- Sponsor's protocol ID
- CCM1421
- Acronym
- EXOPLT
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Exosomes Platelets-released
- ClinicalTrials.gov ID
- NCT06298682
- Acronym / sponsor ID
- EXOPLT / CCM1421
- Conditions
- Platelet Thrombus
- Keywords
- exosomes, platelet activation, platelet inhibitors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 7 Jul 2026 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 7 Mar 2024 (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) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Platelet-derived EVs (PEVs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. The information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited.
Detailed description
This study is a multicentre, observational. We plan to enrol 54 subjects from Centro Cardiologico Monzino IRCCS, and 121 buffy coat related to 121 subjects from Centro Trasfusionale Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. biographical and anthropomorphic data will be recorded, a fasting blood venous sample (from ante-cubital vein) will be collected for the haematochemical analyses and for research samples.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects without known pathologies | – | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- subjects without known pathologies
Key inclusion criteria (1 listed)
- subjects without known pathologies
Key exclusion criteria (14 listed)
- individuals with gastrointestinal diseases,
- individuals with history of hepatic diseases,
- individuals with history of urogenital diseases,
- individuals with history of hematological diseases,
- individuals with history of immunological diseases,
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
Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis
Time frame: 36 month
Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis
Time frame: 36 month
1 secondary outcome
Platelet exosome profile emerged by NTA and proteoma analysis will be related with the "biographical" and "anthropometric" data of the subjects.
Time frame: 40 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Related trials for Platelet Thrombus
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Not yet recruitingObservational study
Comparison of Thrombin Generation, Platelet Activation and Aggregation Profiles in Patients With Sickle Cell Disease Depending on Their SS or SC Genotype (DrepAgreg)
Sickle Cell Disease, Venous Thromboembolism
Not yet recruitingObservational study
Regulation of Platelet Function in Older Patients With Atrial Fibrillation
Atrial Fibrillation, Thrombotic Risk
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Active, not recruiting
The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation
Platelet Aggregation, Spontaneous, Vascular Thrombosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Thrombus, run by Centro Cardiologico Monzino at 1 site in Italy.
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 1 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia S Barbieri, PhD (0258002021, silvia.barbieri@ccfm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis (time frame: 36 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 12 Mar 2024.