[Overview of MELT-Japan].

MELT-Japan was a multicenter randomized controlled trial (RCT) conducted in Japan between 2002 and 2005, in which the efficacy and safety of local fibrinolytic therapy using urokinase for acute ischemic stroke due to middle cerebral artery occlusion was compared with the best medical treatment available at the time. The results were reported in 2007. While there was no difference between the two groups in the primary endpoint (modified Rankin score[mRS], 0-2 at 90 days), the efficacy of endovascular treatment was confirmed in one of the secondary endpoints (mRS, 0-1 at 90 days), and there was no difference in safety between the two groups. MELT-Japan established a foundation for conducting multicenter RCTs, including standardization of treatment methods and imaging diagnostics, and it has assisted clinicians to understand the requirements necessary to plan and conduct RCTs, thus greatly contributing to the subsequent development of clinical research in Japan.