Prospective, open-label safety study of intravenous rtPA in wake-up stroke

They don't bother to tell us the full recovery rate at all to see if it is any better than the current tPA only fully working 12% of the time?
http://www.ncbi.nlm.nih.gov/pubmed/27273860

Barreto AD¹, Fanale CV², Alexandrov AV³, Gaffney KC⁴, Vahidy FS¹, Nguyen CB⁵, Sarraj A¹, Rahbar M^6,7,8, Grotta JC⁹, Savitz SI¹; Wake-Up Stroke Investigators..

Author information

Abstract

OBJECTIVE:

It is estimated that 1 of 4 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 18-80; 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 patient awakening. The primary safety outcome was symptomatic intracerebral hemorrhage (sICH) 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 40 pre-planned patients were enrolled (50% men) at 5 stroke centers. Four patients (10%) were subsequently determined to be mimics. Patients had a mean age of 60.8, median NIHSS of 6.5 (2-24 range) 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 modified Rankin scale 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 non-contrast CT. A randomized effectiveness trial appears feasible using a similar, pragmatic design.

CLINICAL TRIAL REGISTRATION INFORMATION:

www.clinicaltrials.gov Identifier: NCT01183533 This article is protected by copyright. All rights reserved.
© 2016 American Neurological Association.

KEYWORDS:

acute ischemic stroke; clinical trials; thrombolysis; wake-up stroke

PMID:

27273860

[PubMed - as supplied by publisher]