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

NCT ID: NCT05004233

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-13

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ischemic stroke patients

Patients hospitalized for an ischemic stroke.

Group Type EXPERIMENTAL

Blood collection before antiplatelet treatment

Intervention Type BIOLOGICAL

Blood sample (17ml) will be collected in the neurovascular department to be processed for platelet ultrastructural analysis before the onset of an antiplatelet treatment

Blood collection after antiplatelet treatment

Intervention Type BIOLOGICAL

A follow-up will be carried out 5 to 8 days after the initiation of the treatment.

A blood test will be taken in the NeuroVascular Unit

Interventions

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Blood collection before antiplatelet treatment

Blood sample (17ml) will be collected in the neurovascular department to be processed for platelet ultrastructural analysis before the onset of an antiplatelet treatment

Intervention Type BIOLOGICAL

Blood collection after antiplatelet treatment

A follow-up will be carried out 5 to 8 days after the initiation of the treatment.

A blood test will be taken in the NeuroVascular Unit

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PIERRE GARNIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU DE SAINT-ETIENNE

Locations

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Centre Hospitalier Universitaire de St-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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PIERRE GARNIER, MD

Role: CONTACT

(0)477127805 ext. +33

Nora MALLOUK, PhD

Role: CONTACT

(0)4.77.42.14.34 ext. +33

References

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Mallouk N, Garcin A, Li G, Epinat M, Szczepaniak C, Hien OF, Mismetti P, Garnier P. Platelet transmission electron microscopy for the assessment of poor biological response to antiplatelet agent: pilot descriptive and prospective study - ELECTROSTROKE. BMJ Open. 2022 Apr 4;12(4):e050060. doi: 10.1136/bmjopen-2021-050060.

Reference Type DERIVED
PMID: 35379612 (View on PubMed)

Other Identifiers

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2021-A00292-39

Identifier Type: OTHER

Identifier Source: secondary_id

20CH026

Identifier Type: -

Identifier Source: org_study_id

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