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Protocol for the comparison of triflusal and clopidogrel in secondary prevention of stroke based on cytochrome P450 2C19 genotyping (MASETRO study): A multicenter, randomized, open-label, parallel-group trial.

Authors
 Sang Won Han  ;  Yong-Jae Kim  ;  Seong Hwan Ahn  ;  Woo-Keun Seo  ;  Sungwook Yu  ;  Seung-Hun Oh  ;  Youn Nam Kim  ;  Kyung-Yul Lee 
Citation
 International Journal of Stroke, Vol.11(4) : 485-491, 2016 
Journal Title
 International Journal of Stroke 
ISSN
 1747-4930 
Issue Date
2016
MeSH
Brain Ischemia/genetics ; Brain Ischemia/prevention & control ; Cerebral Hemorrhage/genetics ; Cerebral Hemorrhage/prevention & control ; Chemoprevention ; Cytochrome P-450 CYP2C19/genetics* ; Follow-Up Studies ; Genotype ; Humans ; Pharmacogenomic Variants ; Platelet Aggregation Inhibitors/therapeutic use* ; Recurrence ; Salicylates/therapeutic use* ; Secondary Prevention ; Single-Blind Method ; Stroke/genetics* ; Stroke/prevention & control* ; Ticlopidine/analogs & derivatives* ; Ticlopidine/therapeutic use ; Treatment Outcome
Keywords
Antiplatelet ; clopidogrel ; cytochrome P450 2C19 ; prevention ; stroke ; triflusal
Abstract
RATIONALE AND AIM: The antiplatelet effect of clopidogrel is reportedly influenced by cytochrome P450 2C19 (CYP2C19) polymorphisms. However, there is no data concerning the relationship between stroke recurrence and CYP2C19 polymorphisms in patients treated with clopidogrel for secondary prevention of ischemic stroke. Triflusal may be an alternative therapy for clopidogrel in patients with poor genotype. The Comparison of Triflusal and Clopidogrel Effects in Secondary Prevention of Stroke Based on Cytochrome P450 2C19 Genotyping (MAESTRO) study will investigate the effect of antiplatelet agents based on CYP2C19 polymorphisms in secondary prevention of ischemic stroke. SAMPLE SIZE AND DESIGN: Assuming that 55% of patients belong to the poor genotype group, the required sample size is 1080 patients with at least 24 months of follow-up. This study is designed as a prospective, multicenter, randomized, parallel-group, open-label, and blind genotype trial. Patients who experience their first non-cardiogenic ischemic stroke within 30 days prior to screening are eligible. Patients received 300 mg triflusal twice a day or 75 mg clopidogrel once daily during the trial. The study is registered with ClinicalTrials.gov (NCT01174693). STUDY OUTCOME: The primary outcome is recurrent ischemic stroke or hemorrhagic stroke. Secondary outcomes consist of composite major vascular events including stroke, myocardial infarction, coronary revascularization, or vascular death. DISCUSSION: Personalized medicine may be essential for patients according to individual drug metabolism abilities. MAESTRO is the first prospective study designed to evaluate the effect of CYP2C19 polymorphism in secondary stroke prevention and will resolve several questions regarding preventive antiplatelet agents for recurrent stroke.
Full Text
http://wso.sagepub.com/content/11/4/485
DOI
10.1177/1747493015620804
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Neurology (신경과학교실) > 1. Journal Papers
Yonsei Authors
김윤남(Kim, Youn Nam)
이경열(Lee, Kyung Yul) ORCID logo https://orcid.org/0000-0001-5585-7739
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/146804
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