Journal article
Pilot randomized trial of tissue plasminogen activator in acute ischemic stroke
Stroke (1970), Vol.24(7), pp.1000-1004
1993
DOI: 10.1161/01.STR.24.7.1000
PMID: 8322373
Abstract
Background and Purpose: Early thrombolytic therapy with recombinant tissue-type plasminogen activator is a theoretically attractive approach to the treatment of acute focal cerebral ischemia. In preparation for a larger multicenter trial, three centers piloted a protocol for a randomized, double-blind, placebo-controlled trial of intravenous recombinant tissue-type plasminogen activator begun within 3 hours of the onset of symptoms of acute stroke to test its feasibility and to explore trends. Methods: Eligible patients had pretreatment computed tomographic scanning, gave informed consent, and began treatment with either 0.85 mg/kg recombinant tissue-type plasminogen activator or placebo as soon as possible, but no later than 180 minutes after stroke onset. Patients were stratified by whether treatment was begun within 90 minutes or 91 to 180 minutes from onset. The primary end point was the proportion of patients in each group who improved by 4 or more points on the National Institutes of Health Stroke Scale at 24 hours, as determined by a separate blinded evaluator. Results: Twenty-seven patients were randomized: 20 (10 recombinant tissue-type plasminogen activator, 10 placebo) within 90 minutes, and 7 (4 recombinant tissue-type plasminogen activator, 3 placebo) from 91 to 180 minutes. Median baseline Stroke Scale scores were 16 (minimum=5, maximum=26) for the recombinant tissue-type plasminogen activator-treated group and 11 (minimum =3, maximum=21) for the control subjects in the group treated within 90 minutes. Six patients treated with recombinant tissue-type plasminogen activator within 90 minutes improved by 4 or more points at 24 hours compared with 1 patient in the placebo group (P<.05, Fisher’s Exact Test). Two patients in each group in the 91- to 180-minute arm improved. One fatal intracerebral hemorrhage occurred in the placebo group. Conclusions: A randomized, double-blind, placebo-controlled trial of recombinant tissue-type plasminogen activator very early in acute stroke is feasible. Preliminary observations suggest that recombinant tissue-type plasminogen activator treatment within 90 minutes may be associated with early neurological improvement. Larger studies are needed so that the potentially serious short-term risks of this treatment can be assessed in relation to meaningful long-term benefit. © 1993, Stroke. All rights reserved.
Details
- Title: Subtitle
- Pilot randomized trial of tissue plasminogen activator in acute ischemic stroke
- Creators
- E. C Haley - Univ. Virginia school medicine, dep. neurology, Charlottesville VA 22908, United StatesT. G Brott - Univ. Virginia school medicine, dep. neurology, Charlottesville VA 22908, United StatesJ. C Torner - Univ. Virginia school medicine, dep. neurology, Charlottesville VA 22908, United StatesG. L Sheppard - Univ. Virginia school medicine, dep. neurology, Charlottesville VA 22908, United StatesW Barsan - Univ. Virginia school medicine, dep. neurology, Charlottesville VA 22908, United StatesJ Broderick - Univ. Virginia school medicine, dep. neurology, Charlottesville VA 22908, United StatesJ. R Marler - Univ. Virginia school medicine, dep. neurology, Charlottesville VA 22908, United StatesG. L Kongable - Univ. Virginia school medicine, dep. neurology, Charlottesville VA 22908, United StatesJ Spilker - Univ. Virginia school medicine, dep. neurology, Charlottesville VA 22908, United StatesS Massey - Univ. Virginia school medicine, dep. neurology, Charlottesville VA 22908, United StatesC. A Hansen - Univ. Virginia school medicine, dep. neurology, Charlottesville VA 22908, United States
- Resource Type
- Journal article
- Publication Details
- Stroke (1970), Vol.24(7), pp.1000-1004
- DOI
- 10.1161/01.STR.24.7.1000
- PMID
- 8322373
- NLM abbreviation
- Stroke
- ISSN
- 0039-2499
- eISSN
- 1524-4628
- Publisher
- Lippincott Williams & Wilkins
- Language
- English
- Date published
- 1993
- Academic Unit
- Epidemiology; Surgery; Injury Prevention Research Center; Neurosurgery
- Record Identifier
- 9984214717302771
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