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

The Third Affiliated Hospital of Guangzhou Medical University

Status and phase

Unknown

Phase 4

Conditions

Cerebral Infarction

Clopidogrel,Poor Metabolism of (Disorder)

Treatments

Drug: atorvastatin and clopidogrel

Drug: rosuvastatin and clopidogrel

Study type

Interventional

Funder types

Other

Identifiers

NCT02411903

H0906

Details and patient eligibility

About

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）.

Enrollment

160 estimated patients

Sex

All

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Age <85 years and >45 years ,Male or female.
The patient have been Cerebral infarction for one month.
national institutes of health stroke scale（NIHSS）score ≤23 points.
Blood Platelet count greater than 150×10^9／L,and Less than 500×10^9／L.
The patient never do not taking aspirin 、dipyridamole、clopidogrel,or the patient had been taken these anti-platelet drugs but has been discontinued for two weeks at least.
The patient never do not taking Statins or the patient have been stop taking statins 2 weeks for two weeks.

Exclusion criteria

Allergic constitution , or allergic to the composition of the drugs in this study.
national institutes of health stroke scale（NIHSS） score >23 points.
Atrial fibrillation and other cardiogenic cerebral embolism.
Patients who were undergone surgery and trauma (including fractures) within the past three month.
Patients with known dysfunction of vital organs or suffered from Serious cardiovascular disease ，or coagulation disorders.
The patient took Proton pump inhibitors recently.
The history of data collection and the follow-up process can not be saved.