NCT02072226

A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	Alteplase	Single dose of alteplase will be administered at 0.9 milligrams per kilogram (mg/kg) IV (maximal dose of 90 mg).
DRUG	Alteplase Placebo	Single dose of alteplase placebo will be administered as IV injection.
DRUG	Aspirin	Single dose of aspirin will be administered at 325 mg orally.
DRUG	Aspirin Placebo	Single dose of aspirin placebo will be administered orally.

Timeline

• Start date: 2014-05-31
• Primary completion: 2017-03-22
• Completion: 2017-03-22
• First posted: 2014-02-26
• Last updated: 2018-07-03
• Results posted: 2018-07-03

Locations

88 sites across 1 country: United States

Regulatory

• FDA-regulated drug study