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Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators.

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Title: Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators.
Authors: Hacke W (AUTHOR), Kaste M (AUTHOR), Fieschi C (AUTHOR), von Kummer R (AUTHOR), Davalos A (AUTHOR), Meier D (AUTHOR), Larrue V (AUTHOR), Bluhmki E (AUTHOR), Davis S (AUTHOR), Donnan G (AUTHOR), Schneider D (AUTHOR), Diez-Tejedor E (AUTHOR), Trouillas P (AUTHOR), Hacke, W (AUTHOR), Kaste, M (AUTHOR), Fieschi, C (AUTHOR), von Kummer, R (AUTHOR), Davalos, A (AUTHOR), Meier, D (AUTHOR), Larrue, V (AUTHOR)
Source: Lancet. 10/17/1998, Vol. 352 Issue 9136, p1245-1251. 7p.
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 confirm a statistical benefit for alteplase. However, we believe the trend towards efficacy should be interpreted in the light of evidence from previous trials. Despite the increased risk of intracranial haemorrhage, thrombolysis with alteplase at a dose of 0.9 mg/kg in selected patients may lead to a clinically relevant improvement in outcome. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators.
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  Data: <searchLink fieldCode="AR" term="%22Hacke+W%22">Hacke W</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kaste+M%22">Kaste M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fieschi+C%22">Fieschi C</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22von+Kummer+R%22">von Kummer R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Davalos+A%22">Davalos A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Meier+D%22">Meier D</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Larrue+V%22">Larrue V</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bluhmki+E%22">Bluhmki E</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Davis+S%22">Davis S</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Donnan+G%22">Donnan G</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schneider+D%22">Schneider D</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Diez-Tejedor+E%22">Diez-Tejedor E</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Trouillas+P%22">Trouillas P</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hacke%2C+W%22">Hacke, W</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kaste%2C+M%22">Kaste, M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fieschi%2C+C%22">Fieschi, C</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22von+Kummer%2C+R%22">von Kummer, R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Davalos%2C+A%22">Davalos, A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Meier%2C+D%22">Meier, D</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Larrue%2C+V%22">Larrue, V</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 10/17/1998, Vol. 352 Issue 9136, p1245-1251. 7p.
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  Data: <bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Findings: </bold>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.<bold>Interpretation: </bold>The results do not confirm a statistical benefit for alteplase. However, we believe the trend towards efficacy should be interpreted in the light of evidence from previous trials. Despite the increased risk of intracranial haemorrhage, thrombolysis with alteplase at a dose of 0.9 mg/kg in selected patients may lead to a clinically relevant improvement in outcome. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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