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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
Sponsor:
Information provided by (Responsible Party):
Bo Rong Zhou, The Third Affiliated Hospital of Guangzhou Medical University

Brief 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).

Condition or disease Intervention/treatment Phase
Cerebral Infarction Clopidogrel,Poor Metabolism of (Disorder) Drug: atorvastatin and clopidogrel Drug: rosuvastatin and clopidogrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : August 2016


Arm Intervention/treatment
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 :
  1. 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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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Publications of Results:
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Responsible Party: Bo Rong Zhou, chief physicians, The Third Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02411903     History of Changes
Other Study ID Numbers: H0906
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: April 2015

Keywords provided by Bo Rong Zhou, The Third Affiliated Hospital of Guangzhou Medical University:
Clopidogrel-drug interactions

Additional relevant MeSH terms:
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Infarction
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Atorvastatin
Rosuvastatin Calcium
Clopidogrel
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents