Trial | NCT01174693  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    795
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.
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.
Study Started
Mar 31
2010
Primary Completion
Dec 31
2014
Study Completion
Mar 31
2015
Last Update
Mar 17
2015
Estimate

Drug Triflusal

Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014

  • Other names: Disgren®

Drug Clopidogrel

Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014

  • Other names: Plavix®

Clopidogrel Active Comparator

Plavix® 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014

Triflusal Experimental

Disgre® 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014

Criteria 

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
No Results Posted