NCT05572320

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

September 15, 2022

Last Update Submit

April 25, 2026

Conditions

Stroke, AcuteCarotid Artery Diseases

Keywords

Carotid thromboendarterectomyThromboembolic StrokePlatelet functionAggregometryVascular surgerymortalityneurological events

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Occurence of thromboembolic neurological events

    within 1 month of patients' enrolled or before the hospital discharge

  • Occurrence of any complications

    within 1 month of patients' enrolled or before the hospital discharge

  • 6 months and 1 year mortality

    6 months and 1 year

  • 6 months and 1 year neurological events

    6 months and 1 year

Other Outcomes (1)

  • Assesment of the health state at 6 months and 1 year after surgery

    6 months and 1 year

Interventions

Platelet Aggregometry TestingDIAGNOSTIC_TEST

1.6 ml of blood collected in hirudin-coated tubes before the surgery

Also known as: Multiple Electrode Aggregometry (Multiplate) device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing carotid thromboendoarterectomy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific Institute San Raffaele

Milan, 20132, Italy

Location

Related 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.

    PMID: 32856558BACKGROUND

  • 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.

    PMID: 19287328BACKGROUND

  • 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.

    PMID: 21557809BACKGROUND

MeSH Terms

Conditions

StrokeCarotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Fabrizio Monaco, MD

    San Raffaele Scientific Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiothoracic and Vascular Anesthesia

Study Record Dates

First Submitted

September 15, 2022

First Posted

October 7, 2022

Study Start

October 10, 2022

Primary Completion

September 20, 2024

Study Completion

September 20, 2025

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)