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Cited by 3,662Acute Ischemic Stroke ManagementIntracerebral and Subarachnoid Hemorrhage ResearchAcute Myocardial Infarction Research

The DOI matches its Crossref record; 2 of the 2 references it cites were found in a registry or an index.

Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II)

Hacke, Werner, Kaste, Markku, Fieschi, Cesare, von Kummer, Rüdiger, Davalos, Antoni, Meier, Dieter, Larrue, Vincent, Bluhmki, Erich, Davis, Stephen, Donnan, Geoffrey, Schneider, Dietmar, Diez-Tejedor, Exuperio, Trouillas, Paul·1998·The Lancet
DOI 10.1016/s0140-6736(98)08020-9
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Abstract

Background Thrombolysis for acute ischaemic stroke has been investigated in several clinical trials, with variable results. We have assessed the safety and efficacy of intravenous thrombolysis with alteplase (0.9 mg/kg bodyweight) within 6 h of stroke onset. Methods This non-angiographic, randomised, double-blind, trial enrolled 800 patients in Europe, Australia, and New Zealand. Computed tomography was used to exclude patients with signs of major infarction. Alteplase (n=409) and placebo (n=391) were randomly assigned with stratification for time since symptom onset (0-3 h or 3-6 h). The primary endpoint was the modified Rankin scale (mRS) at 90 days, dichotomised for favourable (score 0-1) and unfavourable (score 2-6) outcome. Analyses were by intention to treat. Findings 165 (40.3%) alteplase-group patients and 143 (36.6%) placebo-group patients had favourable mRS outcomes (absolute difference 3.7%, p=0.277). In a posthoc analysis of mRS scores dichotomised for death or dependency, 222 (54.3%) alteplase-group and 180 (46.0%) placebo-group patients had favourable outcomes (score 0-2; absolute difference 8.3%, p=0.024). Treatment differences were similar whether patients were treated within 3 h or 3-6 h. 85 (10.6%) patients died, with no difference between treatment groups at day 90+/-14 days (43 alteplase, 42 placebo). Symptomatic intracranial haemorrhage occurred in 36 (8.8%) alteplase-group patients and 13 (3.4%) placebo-group patients. Interpretation The results do not c…

Overview

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Crossref · 10.1016/s0140-6736(98)08020-9

Cites

2 of 2 references verified0 citation errors · 0 not checkable

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  • If the anticipated case mix is not identified accurately during the design stage, a suboptimal level for dichotomization may be chosen, as appears to have happened in ECASS-2.

    “If the anticipated case mix is not identified accurately during the design stage, then a suboptimal level for dichotomization may be chosen, as appears to have happened in ECASS-2. 6”

    From Statistical Analysis of the Primary Outcome in Acute Stroke Trials (2012) · cites this paper as [6]

  • ECASS-2 was neutral with a dichotomous analysis comparing mRS 0,1 versus 2-6 but positive with a different dichotomization comparing mRS 0-2 versus 3-6 or with a bootstrap analysis.

    “(2) ECASS-2 (alteplase for acute ischemic stroke, Phase III trial) was neutral with a dichotomous analysis (comparison of mRS 0, 1 versus 2-6, the primary analysis) 6 but positive with an analysis using a different dichotomization (mRS 0-2 versus 3-6) 6 or with a bootstrap analysis 7”

    From Statistical Analysis of the Primary Outcome in Acute Stroke Trials (2012) · cites this paper as [6]

Citations

Cites

Flagged first, then by citations

Research works printed but not linked: 17

  1. Donnan, 1996, Streptokinase for acute ischaemic stroke with relationship to time administration, JAMA, 276, 961, 10.1001/jama.1996.03540120039031 · DOI
  2. Multicentre Acute Stroke Trial—Italy (MAST-I) Group, 1995, Randomised controlled trial of streptokinase, aspirin, and combination of both in treatment of acute ischaemic stroke, Lancet, 356, 1509, 10.1016/S0140-6736(95)92049-8 · DOI
  3. Multicenter Acute Stroke Trial—Europe Study Group, 1996, Thrombolytic therapy with streptokinase in acute ischaemic stroke, N Engl J Med, 335, 145, 10.1056/NEJM199607183350301 · DOI
  4. Hacke, 1995, Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric stroke: the European Cooperative Acute Stroke Study (ECASS), JAMA, 274, 1017, 10.1001/jama.1995.03530130023023 · DOI
  5. von Kummer, 1998, Effect of training on the recognition of large ischemic lesions on CT scans obtained within 6 hours of stroke onset, Stroke, 29, 310
  6. Hornig, 1986, Hemorrhagic cerebral infarction: a prospective study, Stroke, 17, 179, 10.1161/01.STR.17.2.179 · DOI
  7. Okada, 1989, Hemorrhagic transformation in cerebral embolism, Stroke, 20, 598, 10.1161/01.STR.20.5.598 · DOI
  8. Stroke Unit Trialists' Collaboration, 1997, Collaborative systematic review of the randomised trials of organized inpatient (stroke unit) care after stroke, BMJ, 314, 1151, 10.1136/bmj.314.7088.1151 · DOI
  9. Ronning, 1998, Stroke units versus general medical wards—I: twelve- and eighteen-month survival; a randomised, controlled trial, Stroke, 29, 58, 10.1161/01.STR.29.1.58 · DOI
  10. Ronning, 1998, Stroke unit versus general medical wards—II: neurological deficits and activities of daily living; a quasi-randomised controlled trial, Stroke, 29, 586, 10.1161/01.STR.29.3.586 · DOI
  11. von Kummer, 1997, Acute stroke: usefulness of early CT findings before thrombolytic therapy, Neuroradiology, 205, 327
  12. Azzimondi, 1997, Variables associated with hospital arrival time after stroke: effect of delay on the clinical efficiency of early treatment, Stroke, 28, 537, 10.1161/01.STR.28.3.537 · DOI
  13. The National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Study Group, 1997, A systems approach to immediate evaluation and management of hyperacute stroke: experience at eight centers and implications for community practice and patient care, Stroke, 28, 1530, 10.1161/01.STR.28.8.1530 · DOI
  14. Steiner, 1998, The ECASS 3-hour cohort: secondary analysis of ECASS data by time stratification, Cerebrovasc Dis, 8, 198, 10.1159/000015851 · DOI
  15. Fisher, 1996, Evolving stroke and the ischemic penumbra, Neurology, 47, 884, 10.1212/WNL.47.4.884 · DOI
  16. Baron, 1995, Treatment of acute ischemic stroke: challenging the concept of a rigid and universal time window, Stroke, 26, 2219, 10.1161/01.STR.26.12.2219 · DOI
  17. Warach, 1995, Acute human stroke studies by whole brain echo planar diffusion-weighted magnetic resonance imaging, Ann Neurol, 37, 231, 10.1002/ana.410370214 · DOI

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Metadata

Authors
Hacke, W., Kaste, M., Fieschi, C., von Kummer, R., Davalos, A., Meier, D., Larrue, V., Bluhmki, E., Davis, S., Donnan, G., Schneider, D., Diez-Tejedor, E., & Trouillas, P.
Affiliations
  • Heidelberg University (DE)
  • University of Helsinki (FI)
  • Technische Universität Dresden (DE)
  • Boehringer Ingelheim (Germany) (DE)
  • Université de Toulouse (FR)
  • The University of Melbourne (AU)
  • Leipzig University (DE)
  • Université de Lyon (FR)
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
1998-10
Volume
352
Issue
9136
Pages
1245-1251
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(98)08020-9
OpenAlex
W2098032054
Cited by
3,662
References
2
Citations by year
2026: 117 · 2025: 135 · 2024: 181 · 2023: 176 · 2022: 193 · 2021: 190 · 2020: 163 · 2019: 153 · 2018: 144 · 2017: 128 · 2016: 124 · 2015: 144 · 2014: 146 · 2013: 145 · 2012: 142
FWCI
89.41
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
Funders
National Institute of Neurological Disorders and Stroke
Topics
  • Health Sciences › Medicine › Clinical Neurology › Acute Ischemic Stroke Management
  • Health Sciences › Medicine › Clinical Neurology › Intracerebral and Subarachnoid Hemorrhage Research
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
Keywords
alteplase, intravenous thrombolysis, acute ischemic stroke, thrombolysis, modified Rankin Scale, functional outcome, symptomatic intracranial hemorrhage, treatment timing, stroke mortality
MeSH terms
Adolescent, Adult, Aged, Aged, 80 and over, Australia, Brain Ischemia, Double-Blind Method, Europe, Female, Fibrinolytic Agents, Humans, Injections, Intravenous, Male, Middle Aged, New Zealand, Tissue Plasminogen Activator, Thrombolytic Therapy, Odds Ratio, Treatment Outcome

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