Stroke, AcuteMULTINEURNCT05572320
Platelet Function and Neurological Events
An observational study of Stroke, Acute and Carotid Artery Diseases, run by Scientific Institute San Raffaele at 1 site in Italy.
Trial summary
Several studies have shown an association between platelet function and stroke in patients undergoing carotid thromboendarterectomy (TEA). The present study will assess the correlation between platelet function evaluated by the impedance aggregometry and neurological events in patients undergoing carotid TEA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Carotid Artery Diseases
- What is being tested?
- Platelet Aggregometry Testing
- How many people
- 650 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2022to 20 Sep 2025
- 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: Patients undergoing carotid thromboendoarterectomy
Who may be able to join
- Age > 18 years
- Carotid Artery Diseases undergoing carotid thrombendarterectomy
- Signed consent
Who cannot join
- Atrial fibrillation
- New oral anticoagulant
- Oral Vitamin k inhibitors
- Platelet count <80000 per microliter
- Ongoing ischemic stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet Function and Neurological Events Following Carotid Thromboendarterectomy
Several studies have shown an association between platelet function and stroke in patients undergoing carotid thromboendarterectomy (TEA).
The present study will assess the correlation between platelet function evaluated by the impedance aggregometry and neurological events in patients undergoing carotid TEA.
Read the detailed description
Carotid thrombendarterectomy (TEA) is effective in preventing strokes which are a major cause of mortality and morbidity. Nevertheless, almost 10% of patients undergoing TEA develop a transient and/or permanent neurological injury. There is a growing body of evidence that platelet function is associated with perioperative neurological events in this setting, although the vast majority of patients undergoing carotid TEA are already on antiplatelet agents. The aim of the present study will be to assess the correlation between the platelet function evaluated by the impedance aggregometry (Multiplate ® Analyzer, Roche, Basel, Switzerland) and neurological events in patients undergoing carotid TEA.
- Conditions
- Stroke, Acute, Carotid Artery Diseases
- Being tested
- Platelet Aggregometry Testing
- Keywords
- Carotid thromboendarterectomy, Thromboembolic Stroke, Platelet function, Aggregometry, Vascular surgery, mortality, neurological events
- Medical subject headings
- Stroke, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Aggregometry TestingDiagnostic test
Also called Multiple Electrode Aggregometry (Multiplate) device
1.6 ml of blood collected in hirudin-coated tubes before the surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet function and neurological events
The platelet function will be evaluated by Multiple Electrode Aggregometry (Multiplate). It will be asses the correlation between thrombin receptor activator peptide 6 (TRAP test), adenosine-5'-diphosphate (ADP test) and arachidonic acid (ASPI test) expressed in arbitrary units area under the curve and neurological events in patients undergoing carotid thrombendarterectomy
Measured: immediately before the surgery
TRAP, ADP and ASPI thresholds to predict neurological events
It will be find the best cut-off for TRAP, ADP and, ASPI in predicting neurological events
Measured: immediately before the surgery
Secondary outcomes (4)
Occurence of thromboembolic neurological events
Measured: within 1 month of patients' enrolled or before the hospital discharge
Occurrence of any complications
Occurrence of surgical and medical complications
Measured: within 1 month of patients' enrolled or before the hospital discharge
6 months and 1 year mortality
Mortality at 6 months and 1 years after carotid surgery
Measured: 6 months and 1 year
6 months and 1 year neurological events
Occurrence of neurological events after 6 months and 1 year after the procedure
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start10 Oct 2022
- Primary completion20 Sep 2024
- Study completion20 Sep 2025
Why it stopped: The principal investigator (PI) has moved to another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- Prospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Monaco, Scientific Institute San Raffaele
- Investigators
- Fabrizio Monaco, MD, Principal investigator, San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572320
- Sponsor's protocol ID
- CE:83/INT/2022
- Acronym
- MULTINEUR
- Status last verified
- Apr 2026
- First submitted
- 15 Sep 2022
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ball STE, Taylor R, McCollum CN. Resistance to Antiplatelet Therapy Is Associated With Symptoms of Cerebral Ischemia in Carotid Artery Disease. Vasc Endovascular Surg. 2020 Nov;54(8):712-717. doi: 10.1177/1538574420947235. Epub 2020 Aug 28.
PubMed 32856558Reavey-Cantwell JF, Fox WC, Reichwage BD, Fautheree GL, Velat GJ, Whiting JH, Chi YY, Hoh BL. Factors associated with aspirin resistance in patients premedicated with aspirin and clopidogrel for endovascular neurosurgery. Neurosurgery. 2009 May;64(5):890-5; discussion 895-6. doi: 10.1227/01.NEU.0000341904.39691.2F.
PubMed 19287328Sacco S, Stracci F, Cerone D, Ricci S, Carolei A. Epidemiology of stroke in Italy. Int J Stroke. 2011 Jun;6(3):219-27. doi: 10.1111/j.1747-4949.2011.00594.x.
PubMed 21557809
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Function and Neurological Events Following Carotid Thromboendarterectomy
- ClinicalTrials.gov ID
- NCT05572320
- Acronym / sponsor ID
- MULTINEUR / CE:83/INT/2022
- Conditions
- Stroke, Acute, Carotid Artery Diseases
- Keywords
- Carotid thromboendarterectomy, Thromboembolic Stroke, Platelet function, Aggregometry, Vascular surgery, mortality, neurological events
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The principal investigator (PI) has moved to another institution
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 7 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.
Several studies have shown an association between platelet function and stroke in patients undergoing carotid thromboendarterectomy (TEA).
The present study will assess the correlation between platelet function evaluated by the impedance aggregometry and neurological events in patients undergoing carotid TEA.
Detailed description
Carotid thrombendarterectomy (TEA) is effective in preventing strokes which are a major cause of mortality and morbidity. Nevertheless, almost 10% of patients undergoing TEA develop a transient and/or permanent neurological injury. There is a growing body of evidence that platelet function is associated with perioperative neurological events in this setting, although the vast majority of patients undergoing carotid TEA are already on antiplatelet agents. The aim of the present study will be to assess the correlation between the platelet function evaluated by the impedance aggregometry (Multiplate ® Analyzer, Roche, Basel, Switzerland) and neurological events in patients undergoing carotid TEA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing carotid thromboendoarterectomy
Key inclusion criteria (3 listed)
- Age > 18 years
- Carotid Artery Diseases undergoing carotid thrombendarterectomy
- Signed consent
Key exclusion criteria (5 listed)
- Atrial fibrillation
- New oral anticoagulant
- Oral Vitamin k inhibitors
- Platelet count <80000 per microliter
- Ongoing ischemic stroke
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 |
|---|---|---|
| Platelet Aggregometry TestingAlso: Multiple Electrode Aggregometry (Multiplate) device1.6 ml of blood collected in hirudin-coated tubes before the surgery | Diagnostic test | – |
Primary outcome
Platelet function and neurological events
Time frame: immediately before the surgery
The platelet function will be evaluated by Multiple Electrode Aggregometry (Multiplate). It will be asses the correlation between thrombin receptor activator peptide 6 (TRAP test), adenosine-5'-diphosphate (ADP test) and arachidonic acid (ASPI test) expressed in arbitrary units area under the curve and neurological events in patients undergoing carotid thrombendarterectomy
TRAP, ADP and ASPI thresholds to predict neurological events
Time frame: immediately before the surgery
It will be find the best cut-off for TRAP, ADP and, ASPI in predicting neurological events
4 secondary outcomes
Occurence of thromboembolic neurological events
Time frame: within 1 month of patients' enrolled or before the hospital discharge
Occurrence of any complications
Time frame: within 1 month of patients' enrolled or before the hospital discharge
6 months and 1 year mortality
Time frame: 6 months and 1 year
6 months and 1 year neurological events
Time frame: 6 months and 1 year
Results and safety
The study was stopped early (reason given: The principal investigator (PI) has moved to another institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 32856558Ball STE, Taylor R, McCollum CN. Resistance to Antiplatelet Therapy Is Associated With Symptoms of Cerebral Ischemia in Carotid Artery Disease. Vasc Endovascular Surg. 2020 Nov;54(8):712-717. doi: 10.1177/1538574420947235. Epub 2020 Aug 28.
- Background: PubMed 19287328Reavey-Cantwell JF, Fox WC, Reichwage BD, Fautheree GL, Velat GJ, Whiting JH, Chi YY, Hoh BL. Factors associated with aspirin resistance in patients premedicated with aspirin and clopidogrel for endovascular neurosurgery. Neurosurgery. 2009 May;64(5):890-5; discussion 895-6. doi: 10.1227/01.NEU.0000341904.39691.2F.
- Background: PubMed 21557809Sacco S, Stracci F, Cerone D, Ricci S, Carolei A. Epidemiology of stroke in Italy. Int J Stroke. 2011 Jun;6(3):219-27. doi: 10.1111/j.1747-4949.2011.00594.x.
- Individual participant dataSharing planned: No
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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.
Fabrizio Monaco, MD principal investigator
San Raffaele Scientific Institute
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 Stroke, Acute and Carotid Artery Diseases, run by Scientific Institute San Raffaele 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 30 Apr 2026. 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?
The study was stopped early (reason given: The principal investigator (PI) has moved to another institution). Results are not available in the source record.
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?
Platelet function and neurological events (time frame: immediately before the surgery). 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?
On the ClinicalTrials.gov record for NCT05572320, which also lists 3 linked publications.
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 30 Apr 2026.