Cerebral Infarction
Conditions
Keywords
prospective, randomized, open label, multi-center, double-blind for CYP2C19 genotypes
Brief summary
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.
Interventions
DRUGTriflusal
Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
DRUGClopidogrel
Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014
Sponsors
Myung In Pharmaceutical Company
Yonsei University
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who have non-cardiogenic ischemic stroke of TOAST classification within 30 days prior to screening 2. ≥ 20 years of age; adult, at the date of signing the informed consent 3. Written informed consent
Exclusion criteria
1. History for bleeding tendency or recent major bleeding within 2 weeks 2. Chronic liver disease (ALT \> 100 IU/L or AST \> 100 IU/L) or renal dysfunction (creatinine \> 4.0 mg/dl) 3. Thrombocytopenia (platelet \< 100,000mm3) 4. Any contraindication of antiplatelet agent 5. Severe congestive heart failure 6. Patients who need to take anticoagulants or two or more antiplatelet agents 7. Severe concomitant disease with the expected survival less than 2 years 8. Pregnant or nursing 9. Any drug clinical trials within 30 days of signing the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first recurrent stroke | 2.8 to 4 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first of composite cardiovascular events, MI or coronary artery revascularization and ischemic stroke | 2.8 to 4 years | 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). |
Countries
South Korea
Outcome results
None listed