TY - JOUR
T1 - A noninferiority confirmatory trial of prasugrel versus clopidogrel in Japanese patients with non-cardioembolic stroke
T2 - rationale and study design for a randomized controlled trial–PRASTRO-I trial
AU - Nagao, Takehiko
AU - Toyoda, Kazunori
AU - Kitagawa, Kazuo
AU - Kitazono, Takanari
AU - Yamagami, Hiroshi
AU - Uchiyama, Shinichiro
AU - Tanahashi, Norio
AU - Matsumoto, Masayasu
AU - Minematsu, Kazuo
AU - Nagata, Izumi
AU - Nishikawa, Masakatsu
AU - Nanto, Shinsuke
AU - Abe, Kenji
AU - Ikeda, Yasuo
AU - Ogawa, Akira
N1 - Funding Information:
aDepartment of Neurology, Nippon Medical School Tama-Nagayama Hospital, Tokyo, Japan; bDepartment of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan; cDepartment of Neurology, Tokyo Women’s Medical University school of Medicine, Tokyo, Japan; dDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; eCenter for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center, International University of Health and Welfare, Tokyo, Japan; fDepartment of Neurology, Saitama Medical University International Medical Center, Saitama, Japan; gDepartment of Neurology, JCHO Hoshigaoka Medical Center, Osaka, Japan; hDepartment of Neurosurgery, Kokura Memorial Hospital, Fukuoka, Japan; iClinical Research Support Center, Mie University Hospital, Mie, Japan; jNishinomiya Municipal Central Hospital, Hyogo, Japan; kBiostatistics & Data Management Department, R&D Division, Daiichi Sankyo Co., Ltd., Tokyo, Japan; lFaculty of Science and Engineering, Waseda University, Tokyo, Japan; mDepartment of Neurosurgery, Iwate Medical University, Iwate, Japan
Funding Information:
This work was supported by Daiichi Sankyo Co., Ltd. (Tokyo, Japan).
Publisher Copyright:
© 2018 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2018/4/13
Y1 - 2018/4/13
N2 - Background: This comparison of PRAsugrel and clopidogrel in Japanese patients with ischemic STROke (PRASTRO)-I trial investigates the noninferiority of prasugrel to clopidogrel sulfate in the prevention of recurrence of primary events (ischemic stroke, myocardial infarction, and death from other vascular causes), and the long-term safety of prasugrel in Japanese patients with non-cardioembolic stroke. Research design and methods: This was an active-controlled, randomized, double-blind, double-dummy, parallel-group study conducted between July 2011 and March 2016 at multiple centers around Japan. Patients had to meet eligibility criteria before receiving 3.75 mg prasugrel or 75 mg clopidogrel orally once daily for a period of 96–104 weeks. Results: A total of 3747 patients were included in this trial; 1598 in the 3.75 mg prasugrel group and 1551 in the 75 mg clopidogrel group completed the study. During the study period, 287 (15.2%) patients in the prasugrel group and 311 (16.7%) in the clopidogrel group discontinued treatment. Baseline characteristics, safety, and efficacy results are forthcoming and will be published separately. Conclusions: This article presents the study design and rationale for a trial investigating the noninferiority of prasugrel to clopidogrel sulfate with regards to the inhibitory effect on primary events in patients with non-cardioembolic stroke.
AB - Background: This comparison of PRAsugrel and clopidogrel in Japanese patients with ischemic STROke (PRASTRO)-I trial investigates the noninferiority of prasugrel to clopidogrel sulfate in the prevention of recurrence of primary events (ischemic stroke, myocardial infarction, and death from other vascular causes), and the long-term safety of prasugrel in Japanese patients with non-cardioembolic stroke. Research design and methods: This was an active-controlled, randomized, double-blind, double-dummy, parallel-group study conducted between July 2011 and March 2016 at multiple centers around Japan. Patients had to meet eligibility criteria before receiving 3.75 mg prasugrel or 75 mg clopidogrel orally once daily for a period of 96–104 weeks. Results: A total of 3747 patients were included in this trial; 1598 in the 3.75 mg prasugrel group and 1551 in the 75 mg clopidogrel group completed the study. During the study period, 287 (15.2%) patients in the prasugrel group and 311 (16.7%) in the clopidogrel group discontinued treatment. Baseline characteristics, safety, and efficacy results are forthcoming and will be published separately. Conclusions: This article presents the study design and rationale for a trial investigating the noninferiority of prasugrel to clopidogrel sulfate with regards to the inhibitory effect on primary events in patients with non-cardioembolic stroke.
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U2 - 10.1080/14656566.2018.1444029
DO - 10.1080/14656566.2018.1444029
M3 - Article
C2 - 29463150
AN - SCOPUS:85044448864
VL - 19
SP - 529
EP - 535
JO - Expert Opinion on Pharmacotherapy
JF - Expert Opinion on Pharmacotherapy
SN - 1465-6566
IS - 6
ER -