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 Neurologic Deficits (PRISMS)
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 Neurologic Deficits (PRISMS)
PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) alteplase in participants with mild acute ischemic strokes that do not appear to be clearly disabling. Participants will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV alteplase and one dose of oral aspirin placebo or 2) one dose of IV alteplase placebo and one dose of oral aspirin 325 milligrams (mg).
Inclusion Criteria:
Exclusion Criteria:
Computed tomography (CT) or magnetic resonance imaging (MRI) findings of one of the following:
Disability prior to the presenting stroke
Standard contraindications to IV alteplase within 3 hours of symptom onset, including:
Allergic reaction to study drug, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs)
Females of childbearing age who are known to be pregnant and/or lactating
Inability to swallow, which would prevent oral intake of aspirin or aspirin placebo tablet
Other serious, advanced, or terminal illness that would confound the clinical outcome at 90 days
Current or recent (within 3 months) participation in another investigational drug treatment protocol
Anticipated inability to obtain 3-month follow-up assessments
Previous enrollment in PRISMS
Any other condition deemed by the investigator that would pose hazard to the participant with alteplase treatment
Newark, Delaware 19718-0002, United States
Miami, Florida 33136, United States
Edgewood, Kentucky 41017, United States