Status:
COMPLETED
Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping
Lead Sponsor:
Gangnam Severance Hospital
Collaborating Sponsors:
Myung In Pharmaceutical Company
Yonsei University
Conditions:
Cerebral Infarction
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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. Hepat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
795 Patients enrolled
Trial Details
Trial ID
NCT01174693
Start Date
March 1 2010
End Date
March 1 2015
Last Update
March 17 2015
Active Locations (18)
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1
Department of Neurology, Wonju Christian Hospital, Yonei University Wonju College of Medicine
Wŏnju, Gangwon-do, South Korea, 220-701
2
Department of Neurology, National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea, 410-719
3
Department of Neurology, CHA Bundang Medical Center, CHA University School of Medicine
Seongnam-si, Gyeonggi-do, South Korea, 463-712
4
Changwon Fatima Hospital
Changwon, Gyeongsangnam-do, South Korea, 641-560