Prasugrel for Japanese patients with acute coronary syndrome in short-term clinical practice (PRASFIT-Practice I): a postmarketing observational study.

ABSTRACT: Data on prasugrel use in Japanese patients are limited to phase II/III clinical trials. This early postmarketing observational study evaluated the safety and efficacy of short-term prasugrel use in patients with acute coronary syndrome (ACS) in real-world clinical settings in Japan. From May 2014 to January 2015, we enrolled consecutive patients with ACS requiring percutaneous coronary intervention in each institution. Each patient started prasugrel treatment ≥1 month before the end of the study period. Safety outcomes included incidence rates of adverse drug reactions (ADRs) and bleeding adverse events (AEs). Efficacy outcomes were incidence rates of cardiovascular events (including major adverse cardiovascular events [MACE]). Case report forms were collected from 749 patients, 732 of who

SUBMITTER: Nakamura M 

PROVIDER: S-EPMC5880844 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature