Abstract 161: Safety of Intravenous Thrombolysis in Wake-up Stroke: A Multicenter, Prospective, Open-label Study
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.
Author Disclosures: A.D. Barreto: Research Grant; Significant; Co-principle investigator of study sponsored by Genentech Inc. C.V. Fanale: None. A.V. Alexandrov: None. K.A. Sands: None. K.C. Gaffney: None. F.S. Vahidy: None. D.D. Navalkele: None. C.C. Tremont: None. R.K. Hamilton: None. C.B. Nguyen: None. A. Sarraj: None. G. Lopez: None. N.R. Gonzales: None. V. Misra: None. T. Wu: Speakers' Bureau; Modest; Genentech Inc. S. Martin-Schild: Speakers' Bureau; Modest; Genentech Inc. J.C. Grotta: None. S.I. Savitz: Research Grant; Significant; Co-principle investigator for study sponsorship by Genentech, Inc.
- © 2015 by American Heart Association, Inc.