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

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

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2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)529-535
Number of pages7
JournalExpert Opinion on Pharmacotherapy
Volume19
Issue number6
DOIs
Publication statusPublished - Apr 13 2018

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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