Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke (AAPIX)
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ClinicalTrials.gov Identifier: NCT01955642 |
Recruitment Status
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Completed
First Posted
: October 7, 2013
Last Update Posted
: December 31, 2015
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Tracking Information | ||||
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First Submitted Date | September 27, 2013 | |||
First Posted Date | October 7, 2013 | |||
Last Update Posted Date | December 31, 2015 | |||
Study Start Date | September 2013 | |||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
adrenergic component of the platelet response [ Time Frame: 5 days after taking clopidogrel ] 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 | Same as current | |||
Change History | Complete list of historical versions of study NCT01955642 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke | |||
Official Title | 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. | |||
Study Type | Observational | |||
Study Design | 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 | |||
Condition |
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Intervention | Drug: Clopidogrel
75 mg milligrams per days of PLAVIX
Other Name: PLAVIX(R) |
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Study Groups/Cohorts | 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 | |||
* 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 | Completed | |||
Actual Enrollment |
91 | |||
Original Estimated Enrollment |
80 | |||
Actual Study Completion Date | December 2015 | |||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01955642 | |||
Other Study ID Numbers | 1208094 2013-000313-20 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Centre Hospitalier Universitaire de Saint Etienne | |||
Study Sponsor | Centre Hospitalier Universitaire de Saint Etienne | |||
Collaborators | Groupe de Recherche sur la Thrombose | |||
Investigators |
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PRS Account | Centre Hospitalier Universitaire de Saint Etienne | |||
Verification Date | December 2015 |