OREANDA-NEWS. Daiichi Sankyo Company, Limited announced the results from the PRASFIT-Elective study, a double-blind randomized phase 3 trial evaluating efficacy and safety of prasugrel hydrochloride (hereafter, prasugrel) plus aspirin versus clopidogrel sulfate (hereafter, clopidogrel) plus aspirin as a reference in elective patients with stable angina and chronic myocardial infarction undergoing PCI.

The study began in Japan in 2011 and patients received 24-48 weeks of either prasugrel or clopidogrel. The primary endpoint of the study was to evaluate the efficacy of prasugrel on the composite events of cardiovascular death, non-fatal myocardial infarction or non-fatal ischemic stroke. The follow-up period for this study has been completed and the anticipated data was obtained.

Based on the results of PRASFIT-Elective and PRASFIT-ACS studies, Daiichi Sankyo expects to submit a New Drug Application (NDA) in Japan in the first half of the Japanese fiscal year 2013 for commercial approval of prasugrel for patients undergoing PCI.

In addition to the above-mentioned studies, a Japan domestic phase 3 trial for patients with ischemic cerebrovascular disease is on-going. This trial is expected to complete in the Japanese fiscal year 2014.

The full results of PRASFIT-Elective will be announced at a future medical congress. However, the data from PRASFIT-ACS will be presented in a late breaking session of the 77th Annual Scientific Meeting of the Japanese Circulation Society to be held in the Pacifico Yokohama on Saturday, March 16.