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

June 14, 2015 updated by: 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）.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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。
For nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H0906

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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