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Studies of streptokinase in acute stroke
The three trials of streptokinase were all terminated early because of increased mortality following treatment
largely as the result of massive brain haemorrhage. Potential contributors to the haemorrhages were thought to be
severe strokes in one trial and high doses of streptokinase administered in all three studies. These studies are
briefly described below.
MAST - I
The Multicentre Acute Stroke Trial - Italy (MAST-I) trial was conducted to see whether individually or
in combination streptokinase and aspirin produce clinical benefits in acute ischaemic stroke in a similar fashion to
those observed in acute myocardial infarction.
The trial was terminated due to early fatalities among the streptokinase group compared with controls.
PubMed Abstract
Reference:
Multicentre Acute Stroke Trial - Italy (MAST-I) Group. Lancet 1995; 346: 1509-1514.
MAST - E
The Muliticentre Acute Stroke Trial - Europe Study Group (MAST - E) was designed to assess the efficacy
and safety of streptokinase in patients with acute ischaemic stroke.
Outcome was measured as a combination of mortality and severe disability at six months. Severe disability was defined as
a score of 3 or higher on the Modified Rankin scale. Primary safety outcomes were mortality at 10 days and cerebral
haemorrhage.
The trial results led to the conclusion that in patients with acute ischaemic stroke, treatment with streptokinase
resulted in increased mortality and therefore that the routine use of streptokinase in patients with acute ischaemic
stroke could not be recommended.
PubMed Abstract
Reference:
The Muliticentre Acute Stroke Trial - Europe Study Group. N Eng J Med 1996; 335: 145-150
ASK
The Australian Streptokinase (ASK) trial was designed to determine whether IV administration of 1.5
million units of streptokinase within 4 hours of the onset of acute ischaemic stroke would reduce morbidity and mortality
at 3 months and whether outcomes may be better for those receiving therapy within 3 hours of stroke onset compared with
those receiving it after 3 hours.
Outcomes were measured as death or disability score (Barthel index <60) three months after the stroke.
The study was terminated early due to increased mortality in the streptokinase group. The authors subsequently reported
that that patients treated within 3 hours of stroke had better outcomes than later treated patients although no
significant benefit over placebo was shown. They concluded that the timing of thrombolytic therapy for acute stroke is
critical.
PubMed Abstract
Reference:
Australian Streptokinase (ASK) Trial Study Group. JAMA 1996; 276: 961-966. |
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© 2005 Boehringer Ingelheim GmbH, Germany. All rights reserved.
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