The Dynamic Effect of Non-cytochrome P450 Isoenzyme 3A4（CYP3A4）-Metabolized and Cytochrome P450 I… (NCT02411903) | Clinical Trial Compass
UnknownPhase 4
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
160 participantsStarted 2015-03
Plain-language summary
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）.
Who can participate
Age range
45 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
incidence of clopidogrel resistance
Timeframe: For nine months
Trial details
NCT IDNCT02411903
SponsorThe Third Affiliated Hospital of Guangzhou Medical University