drugset / Trial / NCT01643902

Safety of Intravenous Thrombolytics in Stroke on Awakening

NCT01643902 ↗

Phase 2 Completed 20 enrolled Johns Hopkins University Genentech, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting standard criteria for treatment with IV tPA for acute stroke. The hypothesis is that patients that wake up with stroke symptoms may have developed the stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the ED within that time, therefore IV tPA should be safe and effective in this population.

Timeline

Start
2013-01
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject tPA Unknown 0.9 mg/kg Intravenous

Indications