MAST-I
Multicentre Acute Stroke Trial-Italy
|
Status:
Trial complete. Results published in December of 1995.
Purpose:
To determine whether, separately or together, streptokinase and aspirin have clinical benefits in acute ischemic stroke similar to those in acute myocardial infarction.
Design:
Randomized, controlled, multi-center, open trial of 622 patients.
Inclusion Criteria
Acute ischemic stroke presenting within 6 hours of symptom onset. No clear indication for or contraindication against streptokinase or aspirin.
Exclusion Criteria
Intracerebral hemorrhage, severe coma without any purposeful motor response, rapid resolution of neurological symptoms, and any medical disorders or exposure to drugs that might interfere with the safety and efficacy evaluation.
Patient Involvement:
CT scan was required prior to randomization. Patients were then randomized with a 2x2 factorial design to either a 1-hour intravenous infusion of 1.5 MU streptokinase, 300 mg/day buffered aspirin for 10 days, both active treatments or neither.
Primary Outcome:
Death or severe disability at 6 months.
Results:
Streptokinase (alone or with aspirin) was associated with a greater number of fatalities at 10 days (odds ratio 2.7, 95% confidence interval 1.7-4.3, 2p<0.00001). Streptokinase (alone or with aspirin) and aspirin (alone or with streptokinase) both reduced the incidence of combined six-month case fatality and severe disability but the difference was not statistically significant (odds ratio for aspirin was 0.9, 95% CI 0.7-1.3, odds ratio for streptokinase was 0.9, 95% CI 0.6-1.3).
Source of Information:
Lancet 1995 Dec 9;346(8989):1509-14.
|
|
Web Links and Publications:
|
|
This information last updated on: 9/21/2000
|
Trials
Directories