MAST-E
Multicenter Acute Stroke Trial-Europe
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Status:
Trial complete. Results published 7/96.
Purpose:
To assess the efficacy and safety of streptokinase in patients with acute ischemic stroke.
Location(s):
France and UK
Design:
Double-blind, controlled trial of 310 patients at 48 centers in France and the UK.
Inclusion Criteria
Moderate-to-severe ischemia in the territory of the middle cerebral artery presenting within 6 hours of onset.
Exclusion Criteria
Mild deficit (MAST score >55), resolution of symptoms before randomization, CT scan showing cerebral hemorrhage or nonvascular disorder, previous hemorrhagic stroke or previous stroke with secondary sequelae, recent surgery or trauma, other illness known to compromise prognoses, known or suspected pregnancy.
Patient Involvement:
156 patients were randomly assigned to receive streptokinase (1.5 million units over a period of one hour) and 154 received placebo. All were evaluated after 6 months.
Primary Outcome:
A binary criterion combining mortality and severe disability at six months, with severe disability defined as a score of 3 or higher on the Rankin scale. The primary safety outcomes were mortality at 10 days and cerebral hemorrhage.
Secondary Outcome:
Death, recurrent cerebrovascular events, and ischemic events.
Results:
The incidence of the primary efficacy outcome was similar in the two groups (124 patients in the streptokinase group and 126 in the placebo group died or had a Rankin score > or = 3). However, the mortality rate at 10 days was significantly higher in the streptokinase group than in the placebo group (34.0 percent vs. 18.2 percent, P = 0.002). The higher rate in the streptokinase group was mainly due to the hemorrhagic transformation of ischemic cerebral infarcts. At six months, more deaths had occurred in the streptokinase group than in the placebo group (73 vs. 59, P = 0.06).
Source of Information:
N Engl J Med 1996 Jul 18;335(3):145-50
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This information last updated on: 9/21/2000
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