Clinical trial NCT05572320: Platelet Function and Neurological Events
Official title: Platelet Function and Neurological Events Following Carotid Thromboendarterectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Carotid Artery Diseases
Keywords: Carotid thromboendarterectomy
Thromboembolic Stroke
Platelet function
Aggregometry
Vascular surgery
mortality
neurological events
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing carotid thromboendoarterectomy

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Platelet function and neurological events
timeFrame: immediately before the surgery
measure: TRAP, ADP and ASPI thresholds to predict neurological events
timeFrame: immediately before the surgery
Secondary outcomes:
measure: Occurence of thromboembolic neurological events
timeFrame: within 1 month of patients' enrolled or before the hospital discharge
measure: Occurrence of any complications
timeFrame: within 1 month of patients' enrolled or before the hospital discharge
measure: 6 months and 1 year mortality
timeFrame: 6 months and 1 year
measure: 6 months and 1 year neurological events
timeFrame: 6 months and 1 year
Other outcomes:
measure: Assesment of the health state at 6 months and 1 year after surgery
timeFrame: 6 months and 1 year
Locations:
city: Milan
country: Italy
facility: Scientific Institute San Raffaele
Study officials:
affiliation: San Raffaele Scientific Institute
name: Fabrizio Monaco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.