Prospective, open-label safety study of intravenous recombinant tissue plasminogen activator in wake-up stroke
Objective It is estimated that one of four ischemic strokes are noticed upon awakening and are not candidates for intravenous recombinant tissue plasminogen activator (rtPA) because their symptoms are >3 hours from last seen normal (LSN). We tested the safety of rtPA in a multicenter, single‐arm,...
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Published in | Annals of neurology Vol. 80; no. 2; pp. 211 - 218 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Blackwell Publishing Ltd
01.08.2016
Wiley Subscription Services, Inc |
Subjects | |
Online Access | Get full text |
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Summary: | Objective
It is estimated that one of four ischemic strokes are noticed upon awakening and are not candidates for intravenous recombinant tissue plasminogen activator (rtPA) because their symptoms are >3 hours from last seen normal (LSN). We tested the safety of rtPA in a multicenter, single‐arm, prospective, open‐label study (NCT01183533) in patients with wake‐up stroke (WUS).
Methods
We aimed to enroll 40 WUS patients with disabling deficits. Patients were 18 to 80 years of age, National Institutes of Health Stroke Scale (NIHSS) ≤25, and selected only on the appearance of noncontrast computed tomography (ie, over one‐third middle cerebral artery territory hypodensity). Standard‐dose (0.9mg/kg) intravenous rtPA had to be started ≤3 hours of patient awakening. The primary safety outcome was symptomatic intracerebral hemorrhage (sICH) with preplanned stopping rules and data safety board oversight. Other endpoints included: asymptomatic intracerebral hemorrhage; clinical improvement in NIHSS; and 90‐day modified Rankin Scale (mRS) score.
Results
Between October 2010 and October 2013, all 40 preplanned patients were enrolled (50% men) at five stroke centers. Four patients (10%) were subsequently determined to be mimics. Patients had a mean age of 60.8, median NIHSS of 6.5 (range, 2–24), and received thrombolysis at a mean time of 10.3 ± 2.6 LSN and 2.6 ± 0.6 hours from awakening with deficits. No sICH or parenchymal hematomas occurred. At 3 months, 20 of 38 (52.6%) patients achieved excellent recovery with mRS scores of 0 or 1 (2 patients were lost to follow‐up).
Interpretation
Intravenous thrombolysis was safe in this prospective WUS study of patients selected by noncontrast CT. A randomized effectiveness trial appears feasible using a similar, pragmatic design. Ann Neurol 2016;80:211–218 |
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Bibliography: | istex:1A30324CFAB1DA85E0B26B29A8CB6DE71D90D3D5 ArticleID:ANA24700 Center for Clinical and Translational Sciences Genentech Inc NIH Clinical and Translational Award - No. UL1 RR024148; No. TL1 RR024147; No. KL2 RR0224149 National Center for Research Resources (NCRR) - No. UL1 TR000371 National Center for Advancing Translational Sciences (NCATS) - No. 5-T32-NS007412-09 ark:/67375/WNG-73W8QCXS-6 NIH www.clinicaltrials.gov Clinical Trial Registration Information Identifier: NCT01183533 ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Article-1 ObjectType-Feature-2 |
ISSN: | 0364-5134 1531-8249 |
DOI: | 10.1002/ana.24700 |