Safety Study of a Recombinant Human Plasminogen Activator to Treat Acute Ischemic Stroke.


Phase 1/2 Results


Thirty-five subjects were enrolled, of whom 33 received the study medication (29 received 0.3 mg/kg, 3 received 0.35 mg/kg, and 1 received 0.4 mg/kg) at a mean dose of 20.4±3.8 mg. The mean age was 69.±11 years, and 60% were male. The median NIHSS score was 13 (range 9 to 38). Sixty-nine percent had large-vessel atherothrombotic stroke and 31% cardioembolic stroke. The mean time to treatment was 3.6±0.97 hours. Two fatal intracerebral hemorrhages (ICH) and 5 asymptomatic ICHs occurred, all in subjects treated in the 3-5 hour time window. Two additional deaths occurred (pneumonia, myocardial infarction). Forty-five percent of subjects had major neurological improvement at 24 hours, as defined by an increase of at least 4 points in the NIHSS. At 90 days, one-third had improved to an NIHSS score of 0-1.