Abstract
Background and Objectives: A significant number of ischemic strokes are noticed upon awakening and are not candidates for intravenous recombinant tissue plasminogen activator (rtPA) due to >3 hours from last seen normal (LSN). We tested the safety of rtPA in a multicenter, single-arm, prospective, open-label study (NCT01183533) of rtPA in patients with wake-up stroke (WUS). Methods: We aimed to enroll 40 WUS patients with disabling deficits. Patients were 18-80; NIHSS ≤25; and selected only on the appearance of non-contrast CT (i.e., <1/3 MCA territory hypodensity). Standard dose (0.9mg/kg) intravenous rtPA had to be started ≤3 hours of awakening. The primary safety outcome was symptomatic intracerebral hemorrhage (ICH) with pre-planned stopping rules and data safety board oversight. Other endpoints included: asymptomatic ICH, clinical improvement in NIHSS and 90-day modified Rankin Scale score (mRS). Results: Between 10/2010 and 10/2013, all pre-planned patients were enrolled. Four patients (10%) were subsequently determined to be mimics. Baseline characteristics, treatment and outcome data are shown in the table. No symptomatic ICH or parenchymal hematomas occurred. Conclusion: Intravenous thrombolysis appears to be safe in WUS patients selected by non-contrast CT. A randomized effectiveness trial appears feasible using a similar, pragmatic design.
Published Version
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