Document Detail

Effect of intravenous recombinant tissue plasminogen activator on ischemic stroke lesion size measured by computed tomography. NINDS; The National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Study Group.
MedLine Citation:
PMID:  11108748     Owner:  NLM     Status:  MEDLINE    
Background and Purpose-When given within 3 hours of symptom onset, recombinant tissue plasminogen activator (rtPA) improves outcome 3 months after ischemic stroke. Prespecified secondary end points of the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial were CT lesion volumes in the 2 treatment groups (tPA and placebo) at 24 hours, 7 to 10 days, and 3 months after stroke. METHODS:-The trial included 2 independent studies, part I and part II, with identical methods of data collection. Before part I, uniform standards were established for CT scanning. CT images were obtained at baseline, 24 hours, 7 to 10 days, and 3 months after stroke onset and were reviewed centrally by reviewers blinded to treatment group and clinical findings. Since the individual studies were not powered to test for lesion volume differences, data from both parts of the trial were combined for all analyses. The primary analysis was conducted with the use of an intention-to-treat algorithm (including patients who died or were lost to follow-up). Measured lesion volume (excluding deaths and those lost to follow-up) was used as a secondary outcome in an exploratory analysis. RESULTS:-After tPA treatment, there was a trend toward a reduction in 3-month median lesion volume in the tPA group: 15 cm(3) (interquartile range, 2 to 87) compared with 24 cm(3) (interquartile range, 4 to 101) in the placebo group (P:=0.06, log model) with a reduction of 11% in cumulative lesion volume, computed with Smirnov's D statistic. After exclusion of deaths and those lost to follow-up, similar trends toward positive treatment effects were seen at all time points. CONCLUSIONS:-The direction of the effect of tPA on CT lesion volume at all time points was consistent with the observed clinical effects at 3 months. CT lesion volume may not be as sensitive a measure of treatment effect as clinical evaluation, at least as used in this study. An intention-to-treat analysis for the radiographic end point in this acute ischemic stroke clinical trial is a less biased approach to account for missing radiographic data than an analysis that uses only measured radiological data.
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Stroke; a journal of cerebral circulation     Volume:  31     ISSN:  1524-4628     ISO Abbreviation:  Stroke     Publication Date:  2000 Dec 
Date Detail:
Created Date:  2000-12-14     Completed Date:  2001-02-08     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0235266     Medline TA:  Stroke     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  2912-9     Citation Subset:  IM    
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MeSH Terms
Brain / radiography*
Cerebral Infarction / drug therapy,  radiography
Double-Blind Method
Fibrinolytic Agents / administration & dosage,  therapeutic use*
Follow-Up Studies
Injections, Intravenous
Middle Aged
Recombinant Proteins / administration & dosage,  therapeutic use
Statistics, Nonparametric
Stroke / drug therapy*,  radiography
Time Factors
Tissue Plasminogen Activator / administration & dosage,  therapeutic use*
Tomography, X-Ray Computed / statistics & numerical data*
Treatment Outcome
Reg. No./Substance:
0/Fibrinolytic Agents; 0/Placebos; 0/Recombinant Proteins; EC Plasminogen Activator

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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