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

Completed

Phase 4 Results N/A

Trial Description

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

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.

Conditions

Interventions

  • Clopidogrel (Plavix®)Drug
    Other Names: Plavix
    Intervention Desc: Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014
    ARM 1: Kind: Experimental
    Label: Clopidogrel
  • Triflusal (Disgren)Drug
    Other Names: Disgren®
    Intervention Desc: Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
    ARM 1: Kind: Experimental
    Label: Triflusal

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Time to first recurrent stroke 2.8 to 3 years No
Secondary Time to first of composite cardiovascular events, MI or coronary artery revascularization and ischemic stroke 2.8 to 3 years No

Sponsors