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NCT Number: NCT05004233

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

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.

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Key information

Conditions

Ischemic Stroke Blood Coagulation Disorders Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hematologic Diseases Hemic and Lymphatic Diseases Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de St-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Magali EPINAT, MD

SUB_INVESTIGATOR

Pierre GARNIER, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood collection before antiplatelet treatment

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

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

Primary outcomes

  1. Morphology of the platelet :

    Time frame: 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

  2. Type of granules in the platelet

    Time frame: 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

  3. Distribution of mitochondria, glycogen and dense tubular system in platelets

    Time frame: 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

  4. Structure of open canalicular system in platelets

    Time frame: 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

  5. Number of patients with a microtubular ring on the equatorial section plane (peripheral or centralized) in platelets

    Time frame: 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 outcomes

  1. The incidence of a composite endpoint

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nora MALLOUK, PhD

CONTACT

[email protected]

(0)4.77.42.14.34 ext. +33

PIERRE GARNIER, MD

CONTACT

[email protected]

(0)477127805 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: ELECTROSTROKE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2021
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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