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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

Primary Purpose

Cerebral Infarction, Clopidogrel,Poor Metabolism of (Disorder)

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
atorvastatin and clopidogrel
rosuvastatin and clopidogrel
Sponsored by
The Third Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring Clopidogrel-drug interactions

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    atorvastatin and Clopidogrel

    rosuvastatin and Clopidogrel

    Arm Description

    80 patients will be taking atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months。

    80 patients will be taking rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months。

    Outcomes

    Primary Outcome Measures

    incidence of clopidogrel resistance
    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。

    Secondary Outcome Measures

    Full Information

    First Posted
    March 17, 2015
    Last Updated
    June 14, 2015
    Sponsor
    The Third Affiliated Hospital of Guangzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02411903
    Brief Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    August 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Third Affiliated Hospital of Guangzhou Medical University

    4. Oversight

    5. Study Description

    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）.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Infarction, Clopidogrel,Poor Metabolism of (Disorder)
    Keywords
    Clopidogrel-drug interactions

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    atorvastatin and Clopidogrel
    Arm Type
    Active Comparator
    Arm Description
    80 patients will be taking atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months。
    Arm Title
    rosuvastatin and Clopidogrel
    Arm Type
    Experimental
    Arm Description
    80 patients will be taking rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months。
    Intervention Type
    Drug
    Intervention Name(s)
    atorvastatin and clopidogrel
    Intervention Description
    Dose: atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months.
    Intervention Type
    Drug
    Intervention Name(s)
    rosuvastatin and clopidogrel
    Intervention Description
    Dose: rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months.
    Primary Outcome Measure Information:
    Title
    incidence of clopidogrel resistance
    Description
    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。
    Time Frame
    For nine months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19829090
    Citation
    Sugunaraj JP, Palaniswamy C, Selvaraj DR, Chaitanya Arudra SK, Sukhija R. Clopidogrel resistance. Am J Ther. 2010 Mar-Apr;17(2):210-5. doi: 10.1097/MJT.0b013e3181bdc3e4.
    Results Reference
    result
    PubMed Identifier
    15837243
    Citation
    Nguyen TA, Diodati JG, Pharand C. Resistance to clopidogrel: a review of the evidence. J Am Coll Cardiol. 2005 Apr 19;45(8):1157-64. doi: 10.1016/j.jacc.2005.01.034.
    Results Reference
    result
    PubMed Identifier
    16386660
    Citation
    Lev EI, Patel RT, Maresh KJ, Guthikonda S, Granada J, DeLao T, Bray PF, Kleiman NS. Aspirin and clopidogrel drug response in patients undergoing percutaneous coronary intervention: the role of dual drug resistance. J Am Coll Cardiol. 2006 Jan 3;47(1):27-33. doi: 10.1016/j.jacc.2005.08.058. Epub 2005 Dec 9.
    Results Reference
    result

    Learn more about this trial

    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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