Platelet Function and Neurological Events

Stroke, Acute Clinical Trial

— MULTINEUR  

Official title:

Platelet Function and Neurological Events Following Carotid Thromboendarterectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05572320
• Other study ID #: CE:83/INT/2022
• Status: Recruiting
• Start date: October 10, 2022
• Est. completion date: September 20, 2025

Study information

• Verified date: January 2024
• Source: Scientific Institute San Raffaele
• Contact: Fabrizio Monaco, MD
• Phone: +39223467176
• Email: monaco.fabrizio[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 386
• Est. completion date: September 20, 2025
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Stroke
• Stroke, Acute

Intervention

Diagnostic Test:
• Platelet Aggregometry Testing
1.6 ml of blood collected in hirudin-coated tubes before the surgery

Locations

Country	Name	City	State
Italy	Scientific Institute San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	Occurence of thromboembolic neurological events		within 1 month of patients' enrolled or before the hospital discharge
Secondary	Occurrence of any complications	Occurrence of surgical and medical complications	within 1 month of patients' enrolled or before the hospital discharge
Secondary	6 months and 1 year mortality	Mortality at 6 months and 1 years after carotid surgery	6 months and 1 year
Secondary	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