Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping

Study Overview
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Brief Summary
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The purpose of this study is to compare the preventive effect of stroke between triflusal and clopidogrel in ischemic stroke patient based on the cytochrome P450 2C19 (CYP2C19) polymorphism.

Detailed Description
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Clopidogrel has anti-platelet activity by irreversible inhibition of the P2Y12 platelet receptor. Clopidogrel must be converted into an active metabolite in order to show anti-platelet activity. Hepatic CYP2C19 enzyme is one of the key hepatic enzymes which convert clopidogrel into active metabolite and its genetic polymorphism is related to clopidogrel resistance. CYP2C19 poor or intermediate metabolizer groups show reduced anti-platelet activity of clopidogrel compared to extensive metabolizer group. This study is designed to prove the superiority of the triflusal in preventing recurrent stroke over the clopidogrel in ischemic stroke patient with poor or intermediate metabolizer of CYP2C19 polymorphism. Also we plan to prove that clopidogrel resistance is related to CYP2C19 polymorphism by comparing the ischemic preventive effect of clopidogrel between groups of different CYP2C19 polymorphism.

Official Title
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Comparison of Triflusal and Clopidogrel Effect in Secondary Prevention of Stroke Based on the Cytochrome P450 2C19 Genotyping

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Drug: Triflusal
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have non-cardiogenic ischemic stroke of TOAST classification within 30 days prior to screening ≥ 20 years of age; adult, at the date of signing the informed consent Written informed consent Exclusion Criteria: History for bleeding tendency or recent major bleeding within 2 weeks Chronic liver disease (ALT > 100 IU/L or AST > 100 IU/L) or renal dysfunction (creatinine > 4.0 mg/dl) Thrombocytopenia (platelet < 100,000mm3) Any contraindication of antiplatelet agent Severe congestive heart failure Patients who need to take anticoagulants or two or more antiplatelet agents Severe concomitant disease with the expected survival less than 2 years Pregnant or nursing Any drug clinical trials within 30 days of signing the informed consent

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clopidogrel<br>Plavix® 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014 | Drug: Clopidogrel<br>* Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014<br>* Other names: Plavix®;|
| Experimental: Triflusal<br>Disgre® 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014 | Drug: Triflusal<br>* Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014<br>* Other names: Disgren®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first recurrent stroke | The study will finish at least 2 years after the recruit of 1080th patients. Until the finish, patients will continuously take study medications and visit every 3months at the study site. We will measure primary outcome during the follow-up period (minimum 2.8 years to maximum 4 years - maximum time is determined by estimated enrollment time period of 2.8 years). | 2.8 to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first of composite cardiovascular events, MI or coronary artery revascularization and ischemic stroke | The study will finish at least 2 years after the recruit of 1080th patients. Until the finish, patients will continuously take study medications and visit every 3months at the study site. We will measure secondary outcomes during the follow-up period (minimum 2.8 years to maximum 4 years - maximum time is determined by estimated enrollment time period of 2.8 years). | 2.8 to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prospective, randomized, open label, multi-center, double-blind for CYP2C19 genotypes