Attendees of the European Stroke Organisation Conference this month had a chance to learn about the OPTIMISTmain trial from its principal investigator, Victor Urrutia, MD. Urrutia is an associate professor of neurology at the Johns Hopkins University School of Medicine and director of the Johns Hopkins Hospital Comprehensive Stroke Center. He presented an e-poster on the trial at the 7th ESOC, which was held virtually this year due to the Covid-19 pandemic.
OPTIMISTmain is a stepped-wedge cluster-randomized trial comparing the standard monitoring protocol for patients who received alteplase for ischemic stroke to a low-intensity monitoring strategy. Investigators hope to assess whether the low-intensity monitoring strategy is non-inferior to the more frequent standard monitoring strategy. Both arms of the trial begin with an initial sequence of intravenous therapy and two hours of monitoring for vital signs and neurological assessments every 15 minutes. After the initial sequence, the low-intensity monitoring arm switches to monitoring every 2 hours for 8 hours and then every 4 hours for 14 hours. In comparison, the standard monitoring arm begins with the initial sequence and is followed by more frequent monitoring: every 30 minutes for 6 hours and then hourly for 16 hours.
Urrutia’s poster indicates that at 16 weeks of recruitment, the trial had enrolled just under 180 participants, which was about 50 patients behind its enrollment target at that point. These enrollments came from 18 actively enrolling trial sites in the U.S. The trial’s total enrollment target is 7200 participants, and investigators plan to continue enrolling participants into 2023.
Though the live conference occurred in early September 2021, registration for ESOC 2021 is still open. Those who register will have access to scientific sessions, e-posters, clinical trial results on-demand until December 3, 2021.