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Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke

NCT ID: NCT01955642

Last Updated: 2015-12-31

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

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-31

Brief Summary

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Ischemic stroke (AIC) is the leading cause of non-traumatic disability in adults, the second leading cause of dementia and the third leading cause of death in France.

Clopidogrel is one of the recommended first line in the secondary prevention of AIC non cardioembolic origin. However recurrences occur in approximately 9% of patients receiving clopidogrel. Some studies in patients with coronary artery disease have made the connection between these treatment failures and non-biological response to clopidogrel. This non-biological response is found for approximately 30% to 50% of patients. Several mechanisms may explain this non-response. The most accepted mechanism is pharmacokinetic. Indeed, clopidogrel is a prodrug that requires intestinal absorption by P-glycoprotein (PGP) and a transformation by hepatic cytochrome into active metabolites. The genetic polymorphism of proteins involved in these two steps explain the low plasma concentration of active metabolites and thus the low efficacy of clopidogrel in some patients.

A new pharmacodynamic hypothesis suggests the involvement of platelet alpha 2-adrenergic receptors. The activation of these receptors potentiates signaling pathway P2Y12 receptor (channel inhibited by clopidogrel) and helps reduce platelet aggregation inhibiting response to clopidogrel.

Detailed Description

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Interest in the biological response to clopidogrel in the AIC is innovative because few data are available in this area. In addition to testing a new pharmacodynamic hypothesis, we also wish to study and compare other measures of platelet function methods in order to be able to use commonly in treatment decisions.

Conditions

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Brain Ischemia Ischemic Attack

Keywords

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Clopidogrel Brain Ischemia Ischemic attack Biological response to clopidogrel

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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AVC

Patients with non-cardioembolic AIC requiring initiation of treatment with clopidogrel as usual indications

Clopidogrel

Intervention Type DRUG

75 mg milligrams per days of PLAVIX

Interventions

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Clopidogrel

75 mg milligrams per days of PLAVIX

Intervention Type DRUG

Other Intervention Names

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PLAVIX(R)

Eligibility Criteria

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Inclusion Criteria

* Consent signed
* Patients with non-cardioembolic AIC requiring initiation of treatment with clopidogrel as usual indications
* normal standard biological tests

Exclusion Criteria

* Need to continue aspirin therapy
* Patients with a recurrence of clopidogrel AIC
* Patient already tacking clopidogrel
* Drugs interfering with the adrenergic system alpha blockers, alpha 2 receptor agonists (alpha-methyldopa) and alpha2 receptor inhibitors (Mianserin, Mirtazapine, yohimbine)
* Contra indication of clopidogrel and / or any of its excipients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe de Recherche sur la Thrombose

OTHER

Sponsor Role collaborator

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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Jerome VARVAT, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2013-000313-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1208094

Identifier Type: -

Identifier Source: org_study_id