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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01955642
Other study ID # 1208094
Secondary ID 2013-000313-20
Status Completed
Phase N/A
First received September 27, 2013
Last updated December 30, 2015
Start date September 2013
Est. completion date December 2015

Study information

Verified date December 2015
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority France: French Data Protection AuthorityFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Clopidogrel
75 mg milligrams per days of PLAVIX

Locations

Country Name City State
France CHU de Saint-Etienne Saint-etienne

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne Groupe de Recherche sur la Thrombose

Country where clinical trial is conducted

France, 

Outcome

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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