Alteplase vs. aspirin on functional outcome for patients with acute ischemic stroke and minor nondisabling neurologic deficits

In the PRISMS trial, researchers evaluated the efficacy and safety of alteplase in patients with acute ischemic stroke presenting with minor neurologic deficits that were considered nondisabling.

In the PRISMS trial, researchers evaluated the efficacy and safety of alteplase in patients with acute ischemic stroke presenting with minor neurologic deficits that were considered nondisabling. The trial was designed as a 948-patient, Phase IIIb, double-blind, double-placebo, multicenter randomized study of alteplase compared with aspirin for emergent stroke at 75 stroke hospital networks around the United States. Participants were randomized to receive I.V. alteplase at the standard dose with oral placebo, or oral aspirin 325 mg with I.V. placebo. For the patients who completed the trial, 78.2% of those in the alteplase group and 81.5% of those in the aspirin group achieved a favorable functional outcome. Although there was no significant difference between the two groups, the researchers report the trial ended early because patient recruitment was below target, so no definitive conclusions can be made, and further research may be needed.