Cerebrovascular DiseaseASTRONCT05247931
Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study
An observational study of Cerebrovascular Disease, run by Fadoi Foundation, Italy at 16 sites in Italy.
Trial summary
Multicenter prospective observational case-control study aimed at characterizing the possible determinants of treatment failure in patients with cerebrovascular disease on secondary prevention with ASA, who are hospitalized in Internal Medicine departments for a recurrent atherothrombotic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine
- How many people
- 100 participants
- Where
- 16 sitesItaly
- Study dates
- 7 Nov 2019to 30 Apr 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with athero-thrombotic stroke, to be divided into CASE group (50 patients experiencing a recurrent stroke while on ASA therapy) and CONTROL group (50 ASA-naïve patients experiencing a first atherothrombotic stroke), with ratio 1:1.
Who may be able to join
- Age ≥18 years
- Swallow-test positive
- Patients hospitalized for a first event of athero-thrombotic stroke (CONTROL group)
- Patients hospitalized for a recurrence of athero-thrombotic stroke on ASA therapy (CASE group)
- Informed Consent
Who cannot join
- Transient ischemic attack (TIA)
- Chronic treatment with non-steroidal anti-inflammatory drugs (if occasional, not within 4 days prior to hospitalization)
- Current treatment with oral or parental anticoagulants at prophylactic or therapeutic doses
- Current treatment with other antiplatelet agents
- Thrombolysis and thrombectomy
- Cardio-embolic stroke CENTRO STUDI FONDAZIONE FADOI Page 10 Studio FADOI.01.2018 Versione n. 2 del 26/09/2019
Show all 17Show fewer
- Carotid stenosis >70%, with indication for revascularization
- Current treatment with ASA (only for patients in the CONTROL group)
- Acute hepatitis, chronic active hepatitis, liver cirrhosis - or alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher than the upper limit of the normal range
- Thrombocytopenia (<150000 platelets/μl)
- Renal failure (eGFR <30 ml/min)
- Active cancer or disease in complete remission <1 year, except squamous cell carcinoma and basal-cell carcinoma of the skin at initial stage
- Severe chronic obstructive pulmonary disease (COPD) (oxygen therapy)
- Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >100 mmHg despite antihypertensive treatment)
- Chronic inflammatory bowel disease
- Chronic treatment with corticosteroid drugs (for example Prednisone >5 mg/die or equivalent)
- Pregnancy (in case of child-bearing potential inclusion will be possible in case of negative pregnancy test)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Italy16 sites, 15 recruiting
- Recruiting
Ospedale di Assisi
Assisi
MANUEL MONTI
MANUEL MONTI
- Active, not recruiting
Ospedale Maggiore di Bologna
Bologna
- Not yet recruiting
Ospedale "S. Cuore di Gesù" Gallipoli
Gallipoli
MARINA SPAGNOLO
LUIGI RIA
- Not yet recruiting
Ospedale Vito Fazzi
Lecce
LEONARDO BARBARINI
LEONARDO BARBARINI
- Not yet recruiting
Ospedale Di Mantova
Mantua
MAURO PAGANI
MAURO PAGANI
- Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan
ARIANNA PANI
FABRIZIO COLOMBO
- Not yet recruiting
P.O. Ostuni-Fasano - ASL BR
Ostuni
PIETRO GATTI
PIETRO GATTI
- Recruiting
IRCCS Mondino
Pavia
FEDERICA FERRARI
ANNAMARIA CAVALLINI
- Recruiting
Azienda Ospedaliera Santa Maria della Misericordia
Perugia
MARA GRAZIANI
MARIAGIULIA MOSCONI
- Not yet recruiting
Ospedale di Pordenone
Pordenone
ALESSANDRO GREMBIALE
MAURIZIO TONIZZO
- Recruiting
Policlinico Gemelli
Roma
IRENE SALA
GIOVANNI FRISULLO
- Recruiting
Ospedale Umberto I - ASP Siracusa
Syracuse
ENZO SANZARO
ENZO SANZARO
- Recruiting
Ospedale Molinette
Torino
CRISTINA ZOCCHI
CRISTINA ZOCCHI
- Not yet recruiting
Ospedale Ca' Foncello di Treviso
Treviso
ROBERTA BUSO
MARCELLO RATTAZZI
- Not yet recruiting
Ospedale di Circolo -ASST Settelaghi
Varese
FEDERICO CARIMATI
MAURIZIO VERSINO
- Not yet recruiting
Ospedale Dei Colli
Viterbo
MARISA DISTEFANO
MARISA DISTEFANO
About this study
Multicenter prospective observational case-control study aimed at characterizing the possible determinants of treatment failure in patients with cerebrovascular disease on secondary prevention with ASA, who are hospitalized in Internal Medicine departments for a recurrent atherothrombotic stroke.
- Conditions
- Cerebrovascular Disease
- Being tested
- TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TXB2 assay of serum , and 11-dehydro-TXB2 assay of urineDiagnostic test
Blood samples are analyzed for the assay of serum TXB2, and urine samples for the assay of 11-dehydro-TXB2
| Study group | Role | What they receive |
|---|---|---|
| CASE | patients experiencing a recurrent stroke while on ASA therapy Receives: Diagnostic Test: TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine | |
| CONTROL | ASA-naïve patients experiencing a first atherothrombotic stroke Receives: Diagnostic Test: TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the rate of recovery of platelet COX-1 activity, measured between 12 and 24 hours after low-dose (100 mg) ASA administration by means of three determinations of serum TXB2 levels, at day 8±1, comparing CASE group vs. CONTROL Group.
To evaluate the rate of recovery of platelet COX-1 activity, measured between 12 and 24 hours after low-dose (100 mg) ASA administration by means of three determinations of serum TXB2 levels, at day 8±1, comparing CASE group vs. CONTROL Group.
Measured: day 8±1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start7 Nov 2019
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANDREA FONTANELLA, Study director, FONDAZIONE FADOI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247931
- Sponsor's protocol ID
- FADOI.01.2018
- Acronym
- ASTRO
- Status last verified
- Feb 2022
- First submitted
- 20 Jan 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study
- ClinicalTrials.gov ID
- NCT05247931
- Acronym / sponsor ID
- ASTRO / FADOI.01.2018
- Conditions
- Cerebrovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 21 Feb 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.
Multicenter prospective observational case-control study aimed at characterizing the possible determinants of treatment failure in patients with cerebrovascular disease on secondary prevention with ASA, who are hospitalized in Internal Medicine departments for a recurrent atherothrombotic stroke.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASE | – | Diagnostic Test: TXB2 assay of serum , and 11-dehydro-TXB2 assay of urinepatients experiencing a recurrent stroke while on ASA therapy |
| CONTROL | – | Diagnostic Test: TXB2 assay of serum , and 11-dehydro-TXB2 assay of urineASA-naïve patients experiencing a first atherothrombotic stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with athero-thrombotic stroke, to be divided into CASE group (50 patients experiencing a recurrent stroke while on ASA therapy) and CONTROL group (50 ASA-naïve patients experiencing a first atherothrombotic stroke), with ratio 1:1.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Swallow-test positive
- Patients hospitalized for a first event of athero-thrombotic stroke (CONTROL group)
- Patients hospitalized for a recurrence of athero-thrombotic stroke on ASA therapy (CASE group)
- Informed Consent
Key exclusion criteria (17 listed)
- Transient ischemic attack (TIA)
- Chronic treatment with non-steroidal anti-inflammatory drugs (if occasional, not within 4 days prior to hospitalization)
- Current treatment with oral or parental anticoagulants at prophylactic or therapeutic doses
- Current treatment with other antiplatelet agents
- Thrombolysis and thrombectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TXB2 assay of serum , and 11-dehydro-TXB2 assay of urineBlood samples are analyzed for the assay of serum TXB2, and urine samples for the assay of 11-dehydro-TXB2 | Diagnostic test | CASE, CONTROL |
Primary outcome
To evaluate the rate of recovery of platelet COX-1 activity, measured between 12 and 24 hours after low-dose (100 mg) ASA administration by means of three determinations of serum TXB2 levels, at day 8±1, comparing CASE group vs. CONTROL Group.
Time frame: day 8±1
To evaluate the rate of recovery of platelet COX-1 activity, measured between 12 and 24 hours after low-dose (100 mg) ASA administration by means of three determinations of serum TXB2 levels, at day 8±1, comparing CASE group vs. CONTROL Group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebrovascular Disease
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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 recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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.
ANDREA FONTANELLA study director
FONDAZIONE FADOI
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Disease, run by Fadoi Foundation, Italy at 16 sites 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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ELISA ZAGARRI', MD (3387063726 ext. +39, elisa.zagarri@fadoi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the rate of recovery of platelet COX-1 activity, measured between 12 and 24 hours after low-dose (100 mg) ASA administration by means of three determinations of serum TXB2 levels, at day 8±1, comparing CASE group vs. CONTROL Group. (time frame: day 8±1). 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 21 Feb 2022.