Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke (AAPIX)
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| First Received Date ICMJE | September 27, 2013 | ||||||||
| Last Updated Date | January 28, 2015 | ||||||||
| Start Date ICMJE | September 2013 | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
adrenergic component of the platelet response [ Time Frame: 5 days after taking clopidogrel ] [ Designated as safety issue: No ] 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) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01955642 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke | ||||||||
| Official Title ICMJE | Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke : Role of Platelet alpha2-adrenergic Receptors | ||||||||
| Brief 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. |
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| Detailed 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Blood DNA |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients with non-cardioembolic AIC requiring initiation of treatment with clopidogrel as usual indications |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Clopidogrel
75 mg milligrams per days of PLAVIX
Other Name: PLAVIX(R) |
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| Study Group/Cohort (s) | AVC
Patients with non-cardioembolic AIC requiring initiation of treatment with clopidogrel as usual indications
Intervention: Drug: Clopidogrel |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | December 2015 | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01955642 | ||||||||
| Other Study ID Numbers ICMJE | 1208094, 2013-000313-20 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Collaborators ICMJE | Groupe de Recherche sur la Thrombose | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Verification Date | January 2015 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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