Randomized Trial of Intraarterial Infusion of Urokinase Within 6 Hours of Middle Cerebral Artery Stroke

• DOI: 10.1161/strokeaha.107.488551
• Publication Date: 2007-08-17T00:54:47Z
• Authors: Akira Ogawa; Etsuro Mori; Kazuo Minematsu; Waro Taki; Akira Takahashi; Shigeru Nemoto; Susumu Miyamoto; Makoto Sasaki; Takashi Inoue
• Keywords: Stroke; Clinical endpoint

Background and Purpose— The Middle Cerebral Artery Embolism Local Fibrinolytic Intervention Trial (MELT) Japan was organized to determine the safety clinical efficacy of intraarterial infusion urokinase (UK) in patients with stroke within 6 hours onset. Methods— Patients ischemic presenting onset displaying occlusions M1 or M2 portion middle cerebral artery on carotid angiography were randomized UK control groups. Clinical outcome assessed by modified Rankin Scale, National Institutes Health Stroke Barthel Index. Results— Independent Monitoring Committee recommended stopping trial after approval intravenous recombinant tissue plasminogen activator Japan. A total 114 underwent randomization, 57 each group. characteristics comparable between 2 primary end point favorable (modified Scale 0 2) at 90 days somewhat more frequent group than (49.1% 38.6%, OR: 1.54, 95% CI: 0.73 3.23) but did not reach a significant level ( P =0.345). However, excellent functional 1) days, preplanned secondary point, (42.1% 22.8%, =0.045, 2.46, 1.09 5.54). There significantly 1 =0.017). 90-day cumulative mortality 5.3% 3.5% =1.000), intracerebral hemorrhage 24 treatment occurred 9% 2%, respectively =0.206). Conclusions— aborted prematurely statistical significance. Nevertheless, analyses suggested that fibrinolysis has potential increase likelihood outcome.