Background and Purpose: The Middle Cerebral Artery Embolism Local Fibrinolytic Intervention Trial (MELT) Japan was organized to determine the safety and clinical efficacy of intra-arterial infusion of urokinase (UK) in patients with ischemic stroke within 6 hours of onset.
Methods: Patients with ischemic stroke presenting within 6 hours of onset and displaying occlusions of the M1 or M2 portion were randomized to the UK or control groups. Clinical outcome was assessed by the modified Rankin Scale (mRS).
Results: A total of 114 patients underwent randomization, 57 patients in each group. The primary end-point (mRS 0-2) at 90 days was somewhat more frequent in the UK group than in the control group (49.1% and 38.6%) but did not reach significant level. However, excellent functional outcome (mRS 0-1) at 90 days, a preplanned secondary endpoint, was more frequent in the UK group than in the control group (42.1% and 22.8%, p=0.045).
Conclusions: The trial was aborted prematurely and the primary end point did not reach statistical significance. Nevertheless, the secondary analyses suggested that intra-arterial fibrinolysis has the potential to increase the likelihood of excellent functional outcome.