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

Expert Opinion on Pharmacotherapy
Takehiko NagaoAkira Ogawa

Abstract

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. 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. 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. This article presents the study design and rationale for a trial investigating the noninferiority of prasugrel to clopidogrel sulfate with regards to...Continue Reading

References

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Citations

Jun 5, 2020·Journal of Atherosclerosis and Thrombosis·Takanari KitazonoUNKNOWN PRASTRO-I Study Group
Aug 19, 2020·International Journal of Environmental Research and Public Health·Salvatore Santo SignorelliAgostino Gaudio
Feb 11, 2021·Stroke; a Journal of Cerebral Circulation·Kazunori ToyodaUNKNOWN PRASTRO Trial Investigators*

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