Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping
- Registration Number
- NCT01174693
- Lead Sponsor
- Gangnam Severance Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 795
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clopidogrel Clopidogrel Plavix® 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014 Triflusal Triflusal Disgre® 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (18)
Department of Neurology, Wonju Christian Hospital, Yonei University Wonju College of Medicine
🇰🇷Wonju-si, Gangwon-do, Korea, Republic of
Department of Neurology, National Health Insurance Corporation Ilsan Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Department of Neurology, CHA Bundang Medical Center, CHA University School of Medicine
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Changwon Fatima Hospital
🇰🇷Changwon, Gyeongsangnam-do, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Department of Neurology, Severance Hospital, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
KyungHee University Medical Center
🇰🇷Seoul, Korea, Republic of
Department of Neurology, National Medical Center
🇰🇷Seoul, Korea, Republic of
Department of Neurology, Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Department of Neurology, Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Department of Neurology, Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine
🇰🇷Seoul, Korea, Republic of
Department of Neurology, Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Department of Neurology, Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of