Author(s) |
(a) and (b) The AIMS group
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Title(s) |
a) Effect of intravenous APSAC on mortality after acute myocardial infarction: preliminary report of a placebo-controlled clinical trial
(b) Long-term effects of intravenous anistreplase in acute myocardial infarction: final report of the AIMS study
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Reference(s) |
(a) Lancet 1988;i:545-9
(b) Lancet 1990;335:427-31
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Disease |
AMI
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Purpose |
To investigate the effects of anisoylated plasminogen streptokinase activator complex (APSAC) on survival rates for up to 1 year after AMI
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Study design |
Randomised, double-blind, placebo-controlled
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Follow-up |
1 year
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Patients |
Aim 2000 patients, but only 1004 patients (502 in each group) recruited (see comments), aged ≤ 70 years
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Treatment regimen |
APSAC, 300 U iv bolus over 5 min within 6 h of onset of symptoms, or placebo
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Concomitant therapy |
Heparin iv. Ancillary therapy administered according to normal practice. Beta-blockers given on discharge from hospital
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Results |
At 30 days, 6% of patients in the APSAC group had died compared to 12% in the placebo group. At 1 year, the mortality rates were 11% and 18%, respectively. Major complications of AMI were less common in the APSAC group than in the controls
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Comments |
It was considered unethical to continue to randomise patients to a placebo treatment arm because of the 47% reduction in the 30-day mortality in patients receiving APSAC. Patient entry to the trial was terminated in November 1987
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