Brain Ischemia Clinical Trial
— AAPIXOfficial title:
Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke : Role of Platelet alpha2-adrenergic Receptors
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.
Status | Completed |
Enrollment | 91 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | CHU de Saint-Etienne | Saint-etienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Groupe de Recherche sur la Thrombose |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | adrenergic component of the platelet response | adrenergic component of the platelet response is estimated by the difference between the maximum percentage of platelet aggregation by light transmission aggregometry (LTA) with the addition of ADP(adenosine diphosphate) + ADP versus selective agonist (epinephrine) | 5 days after taking clopidogrel | No |
Secondary | VASP-CMF | Platelet reactivity index (PRI) by VASP CMF (flow cytometry) method | After 5 days taking clopidogrel | No |
Secondary | ELISA VASP | Platelet reactivity index (PRI-ELISA) using ELISA VASP | After 5 days taking clopidogrel | No |
Secondary | active metabolite of clopidogrel | Rate of residual plasma active metabolite of clopidogrel (R-130964) | After 5 days taking clopidogrel | No |
Secondary | Genotyping of MDR-1 and P450 2C19 | Genotyping of MDR-1 and P450 2C19 | After 5 days taking clopidogrel | No |
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