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)
The primary objective of this study is to determine the efficacy of intravenous (IV) alteplase for treatment of acute ischemic stroke (AIS) in patients with mild stroke (also known as “minor neurologic deficit” and “rapidly improving stroke symptoms”), defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤ 5 and not clearly disabling, within 3 hours of last known well time as measured by the proportion of patients with a modified Rankin Scale (mRS) 0−1 at Day 90.
Neuroscience - Stroke,
Aaron Stayman, MD
- Age ≥ 18 years (no upper age limit)
- Mild ischemic stroke defined as the most recent pre-treatment NIHSS score of ≤ 5 and determined as not clearly disabling by the investigator. This includes patients with persistently mild deficits as well as thos who improve to a pre-treatment NIHSS score ≤ 5 (also known as RISS).
- Study treatment can be initiated within 3 hours of last known well time without stroke symptoms (i.e., last seen normal)
- Computed tomography (CT) or magnetic resonance imaging (MRI) findings consisting of one of the following:
- Clear large hypodensity on CT (or concurrent diffusion-weighted and fluid attenuated inversion recovery hyperintensity on MRI) that is greater than one-third middle cerebral artery (MCA) territory or greater than 100 cc if not in MCA territory
- Imaging lesion consistent with acute hemorrhage of any degree, OR
- Evidence of intraparenchymal tumor
- Disability (historical mRS score ≥ 2) prior to the presenting stroke
- Standard contraindications to IV alteplase for patients treated within 3 hours of symptom onset.
- Allergic reactions to study drug or aspirin
- Females of childbearing age who are known to be pregnant and/or lactating, or who have a positive pregnancy test on admission
- 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 that the investigator feels would pose a significant hazard to the patient if treatment with alteplase is initiated