A Phase IIIb, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients with Mild Stroke: Rapidly Improving Symptoms and Minor Neurological Deficits (PRISMS)
ID Number 14-1237Principal Investigator(s)
Aaron P Tansy
Department(s) or Division(s)
This is a double blind, multicenter, randomized, phase IIIB, study to evaluate the efficacy and safety of Intravenous alteplase in Acute Ischemic stroke (AIS) in patients with mild ischemic strokes (also known as "minor neurologic deficit" and "rapidly improving stroke symptoms") that are not clearly disabling on presentation. The trial will consist of a screening assessment, randomization, and treatment followed by a 30-day phone call and 90 day follow up visit. The patients will receive treatment 3 hours from the last known well time of the stroke symptoms onset. Eligibility for study enrollment will be predicated on all screening assessment criteria being first met. After patients have met eligibility criteria and have been enrolled in the study, their treatment will be determined through a computer-aided randomization with a 1:1 ratio as follows
1) Alteplase and oral aspirin placebo
2) One dose of Alteplase-Placebo and one oral aspirin tablet
All relevant parties including the patients and research staff will be blinded to the treatments to which the patients have been randomized and given.
Approximately 948 patients with acute ischemic stroke meeting study assessment criteria will be enrolled across multiple participating centers. 15 subjects will be enrolled at this site.
Recruiting Patients: Yes