Platelet Function and Neurological Events (MULTINEUR)

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.

Study Overview

• Status: Terminated
• Conditions: Carotid Artery Diseases; Stroke, Acute
• Intervention / Treatment: Diagnostic test: Platelet Aggregometry Testing

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 Type: Observational
• Enrollment (Actual): 650

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • Scientific Institute San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing carotid thromboendoarterectomy

Description

Inclusion Criteria:

• Age > 18 years
• Carotid Artery Diseases undergoing carotid thrombendarterectomy
• Signed consent

Exclusion Criteria:

• Atrial fibrillation
• New oral anticoagulant
• Oral Vitamin k inhibitors
• Platelet count <80000 per microliter
• Ongoing ischemic stroke

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	immediately before the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of thromboembolic neurological events		within 1 month of patients' enrolled or before the hospital discharge
Occurrence of any complications	Occurrence of surgical and medical complications	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	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	6 months and 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assesment of the health state at 6 months and 1 year after surgery	The health state will be evaluated by EuroQol 5-dimensions 3 level test at 6 months and 1 year	6 months and 1 year

Collaborators and Investigators

• Sponsor: Scientific Institute San Raffaele
• Investigators: Principal Investigator: Fabrizio Monaco, MD, San Raffaele Scientific Institute

Publications and helpful links

General 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.
• Reavey-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.
• Sacco 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 20, 2025

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mortality; Platelet function; Vascular surgery; Carotid thromboendarterectomy; Thromboembolic Stroke; Aggregometry; neurological events
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Carotid Artery Diseases
• Other Study ID Numbers: CE:83/INT/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No