A noninferiority confirmatory trial of prasugrel versus clopidogrel in Japanese patients with non-cardioembolic stroke: rationale and study design for a randomized controlled trial - PRASTRO-I trial

作者：Nagao Takehiko; Toyoda Kazunori; Kitagawa Kazuo; Kitazono Takanari; Yamagami Hiroshi; Uchiyama Shinichiro; Tanahashi Norio; Matsumoto Masayasu; Minematsu Kazuo; Nagata Izumi; Nishikawa Masakatsu; Nanto Shinsuke; Abe Kenji; Ikeda Yasuo; Ogawa Akira

来源：Expert Opinion on Pharmacotherapy, 2018, 19(6): 529-535.

DOI：10.1080/14656566.2018.1444029

• Antiplatelet
• ischemic event
• clopidogrel sulfate
• prasugrel
• non-cardioembolic stroke

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 3.75mg prasugrel or 75mg clopidogrel orally once daily for a period of 96-104weeks.Results: A total of 3747 patients were included in this trial; 1598 in the 3.75mg prasugrel group and 1551 in the 75mg 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.

• 出版日期2018