Does study enrollment delay treatment with intravenous thrombolytics for acute ischemic stroke?

BACKGROUND AND PURPOSE Enrollment in acute stroke trials at a stroke center with multiple study protocols may delay the initiation of intravenous thrombolytics in patients who present within 3 hours of symptom onset. METHODS We studied all patients presenting with acute ischemic stroke over the past 3.5 years who qualified for thrombolysis within 3 hours of symptom onset. We collected demographics, baseline National Institutes of Health Stroke Scale scores, CT findings, and arrival-to-treatment times and compared patients treated with intravenous thrombolytics in a clinical trial with patients who received standard of care intravenous tissue plasminogen activator. RESULTS Of 290 treated patients, 19 were enrolled in prelytic studies, 46 were enrolled in postlytic studies, and 225 were treated with standard intravenous tissue plasminogen activator. There was no significant difference in age, gender, National Institutes of Health Stroke Scale score, admission glucose, or changes on CT. There was no difference in onset-to-arrival time or arrival-to-treatment time between patients enrolled in clinical studies and those who received standard treatment. However, among study patients, prelytic randomization led to a significantly longer arrival-to-treatment time by 13 minutes (P=0.028). CONCLUSIONS We found that trials requiring prethrombolytic randomization can lead to a delay in the initiation of treatment. Future studies are needed to determine if such a delay is clinically significant and can be shortened by improved enrollment strategies.