Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischemic Stroke "ATLANTIS"

Completed

Phase 3 Results

Results

In the target population, 32% of placebo patients and 34% of rt-PA patients had NIHSS score <=1 at 90 days (p=0.65). There were no differences in any of the secondary functional outcome measures. Adverse events included significant increases in the rate of symptomatic intracerebral hemorrhage (ICH) (1.1% vs. 7.0%, p<0.001), asymptomatic ICH (4.7% vs. 11.4%, p=0.004), and fatal ICH (0.3% vs. 3.0%, p<0.001). Mortality at 90 days was 6.9% in placebo patients and 11.0% with rt-PA (p=0.09).