title: 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.
abstract: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.
authors.forename: Sang Won
authors.initials: SW
authors.lastname: Han
authors.affiliation: Department of Neurology, Ewha Womans University School of Medicine, Seoul, Korea.
authors.forename: Yong-Jae
authors.initials: YJ
authors.lastname: Kim
authors.affiliation: Department of Neurology, Chosun University School of Medicine, Gwangju, Korea.
authors.forename: Seong Hwan
authors.initials: SH
authors.lastname: Ahn
authors.affiliation: Departments of Neurology, College of Medicine, Korea University, Seoul, Korea.
authors.forename: Woo-Keun
authors.initials: WK
authors.lastname: Seo
authors.affiliation: Departments of Neurology, College of Medicine, Korea University, Seoul, Korea.
authors.forename: Sungwook
authors.initials: S
authors.lastname: Yu
authors.affiliation: Department of Neurology, CHA University College of Medicine, Bundang, Korea.
authors.forename: Seung-Hun
authors.initials: SH
authors.lastname: Oh
authors.affiliation: Clinical Trials Center, Severance Hospital, Yonsei University Health System, Seoul, Korea.
authors.forename: Youn Nam
authors.initials: YN
authors.lastname: Kim
authors.affiliation: Department of Neurology, Yonsei University College of Medicine, Seoul, Korea kylee@yuhs.ac.
authors.forename: Kyung-Yul
authors.initials: KY
authors.lastname: Lee
mesh_terms: D002545:Brain Ischemia / Q000235:genetics / Q000517:prevention & control; D002543:Cerebral Hemorrhage / Q000235:genetics / Q000517:prevention & control; D018890:Chemoprevention; D000077144:Clopidogrel; D065731:Cytochrome P-450 CYP2C19 / Q000235:genetics*; D005500:Follow-Up Studies; D005838:Genotype; D006801:Humans; D000071184:Pharmacogenomic Variants; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D012008:Recurrence; D012459:Salicylates / Q000627:therapeutic use*; D055502:Secondary Prevention; D016037:Single-Blind Method; D020521:Stroke / Q000235:genetics* / Q000517:prevention & control*; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D012459:Salicylates; C016167:triflusal; D000077144:Clopidogrel; D065731:Cytochrome P-450 CYP2C19; D013988:Ticlopidine
keywords: Antiplatelet; clopidogrel; cytochrome P450 2C19; prevention; stroke; triflusal