The Dynamic Effect of Non-cytochrome P450 Isoenzyme 3A4（CYP3A4）-Metabolized and Cytochrome P450 Isoenzyme 3A4（CYP3A4）-Metabolized Statins on Clopidogrel Resistance in Patients With Cerebral Infarction
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|ClinicalTrials.gov Identifier: NCT02411903|
Recruitment Status : Unknown
Verified April 2015 by Bo Rong Zhou, The Third Affiliated Hospital of Guangzhou Medical University.
Recruitment status was: Enrolling by invitation
First Posted : April 8, 2015
Last Update Posted : June 16, 2015
The Third Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Bo Rong Zhou, The Third Affiliated Hospital of Guangzhou Medical University
The investigators team had found that the presence of dynamic changes of Clopidogrel resistance are not associated with genetic factors. Currently, study on moderate doses of statins and dynamic Clopidogrel resistance has not been reported, therefore this study will observe 160 cases of open prospective secondary prevention in patients with cerebral infarction. Excluded: those patients occurs Clopidogrel resistance because of slow metabolism caused by cytochrome P450 isoenzyme 2C19（CYP2C19, and then observed the impact of the cytochrome P450 isoenzyme 3A4 （CYP3A4）-metabolized and non-cytochrome P450 isoenzyme 3A4 （CYP3A4）—metabolized statins dynamically on Clopidogrel resistance in the next 9 months, adverse events will be recorded, the metabolite of clopidogrel（H4 ）and the polymorphism of cytochrome P450 isoenzyme 2C19 （CYP2C19）/cytochrome P450 isoenzyme 3A4 （CYP3A4）/ cytochrome P450 isoenzyme 2C9（CYP2C9）will be detected. Expected Result: the patients use the cytochrome P450 isoenzyme 3A4（CYP3A4）-metabolized statins will result in dynamic Clopidogrel resistance easily ,H4 levels will decline, and Clopidogrel resistance is not related to the polymorphism of cytochrome P450 isoenzyme 3A4 （CYP3A4）.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Infarction Clopidogrel,Poor Metabolism of (Disorder)||Drug: atorvastatin and clopidogrel Drug: rosuvastatin and clopidogrel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||August 2016|
Active Comparator: atorvastatin and Clopidogrel
80 patients will be taking atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months。
Drug: atorvastatin and clopidogrel
Dose: atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months.
Experimental: rosuvastatin and Clopidogrel
80 patients will be taking rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months。
Drug: rosuvastatin and clopidogrel
Dose: rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months.
Primary Outcome Measures :
- incidence of clopidogrel resistance [ Time Frame: For nine months ]Definition of clopidogrel resistance is the absolute change of 5 microliter adenosine diphosphate(ADP) induced PAR≤10% as compared to baseline. So, incidence of clopidogrel resistance= (PAR at monitor point - PAR at baseline) / PAR at baseline×100 %≤10 %。 Measures of PAR: PAR is measured by Light transmittance aggregometry (LTA) and according to the standard of Rev。
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