Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent

Not Applicable

Recruiting

• Conditions: Ischemic Stroke
• Interventions: Biological: Blood collection before antiplatelet treatment; Biological: Blood collection after antiplatelet treatment

• Registration Number: NCT05004233
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

The aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke ; and to assess recurrence of Ischemic Cerebral Accident (ICA) at 6 months in patients hospitalized for Ischemic stroke.

Detailed Description

Ischaemic stroke is the leading cause of adult disability. Thus, a strategy based on an efficient antiplatelet therapy has been developed to prevent platelet activation occurring in the acute phase of non-cardioembolic ischemic stroke.

The biological monitoring of the antiplatelet therapy with available platelet function assays do not provide a global integrative approach considering all the mechanisms involved in platelet activation.

Platelet transmission electron microscopy recently validated for assessing distinct ultrastructural abnormalities is a reliable morphological platelet structural analysis tool.

Ultrastructural criteria could be identified and be useful for the assessment of the degree of platelet activation and thus the biological efficiency of antiplatelet agents. All the activation transduction signals are integrated and all antiplatelet agents can be assessed.

The aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke.

Investigators expect to identify ultrastructural characteristics that will be correlated with the platelet degree of activation to guide clinicians in decision-making regarding the antiplatelet therapy strategy.

Study Timeline

• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-13
• Status Verified: 2024-12
• Study Start: 2024-12-13
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Social security affiliation
• Signed informed consent
• patients hospitalized for an non cardioembolic ischemic stroke requiring the onset of an antiplatelet therapy according to the usual guidelines recommendations

Exclusion Criteria

Contraindications regarding antiplatelet agent(s) and/or at least one excipient according to Summary of Product Characteristics (SPC).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ischemic stroke patients	Blood collection before antiplatelet treatment	Patients hospitalized for an ischemic stroke.
Ischemic stroke patients	Blood collection after antiplatelet treatment	Patients hospitalized for an ischemic stroke.

Primary Outcome Measures

Name	Time	Method
Number of patients with a microtubular ring on the equatorial section plane (peripheral or centralized) in platelets	Day 5	Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA
Type of granules in the platelet	Day 5	Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA; - the observation of granules : * alpha granules; * dense granules
Morphology of the platelet :	Day 5	Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA; the morphology of the platelet : * discoid or round; * with the emission of filipodia, pseudopodia and lamellipodia
Structure of open canalicular system in platelets	Day 5	Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA; - the open canalicular system; * dilated or not; * associated with degranulation or not
Distribution of mitochondria, glycogen and dense tubular system in platelets	Day 5	Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA

Secondary Outcome Measures

Name	Time	Method
The incidence of a composite endpoint	Month 6	The incidence of a composite of cardiovascular events (radiologically documented recurrent ischemic stroke, transient ischemic attacks, coronary artery disease (acute coronary syndromes, myocardial infarction), obliterating arterial disease of the lower limb, death of cardiovascular origin)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de St-Etienne; 🇫🇷 Saint-Étienne, France