Stroke, Vol 14, 5-14, Copyright © 1983 by American Heart Association
MG Bousser, E Eschwege, M Haguenau, JM Lefaucconnier, N Thibult, D Touboul and PJ Touboul
604 Patients with atherothrombotic cerebral ischemic events (transient,
16%: or completed, 84%) referrable either to the carotid or to the
vertebral-basilar circulation were entered into a double blind randomized
clinical trial (AICLA) to determine whether aspirin (A) (1 g/day) or
aspirin (1 g/day) + Dipyridamole (225 mg/day) (AD) would produce a
significant reduction in the subsequent (3 years) occurrence of fatal and
nonfatal cerebral infarction. Randomization produced remarkably comparable
treatment groups and this good comparability was maintained throughout the
study. Adherence to the protocol and drug compliance were excellent. Side
effects, particularly symptoms of peptic ulcer and hemorrhagic events were
significantly (p less than 0.03) more frequent in the two treatment groups
containing aspirin. With the exception of patients who withdrew from the
study, each patient was followed for 3 years. At the end of the study, the
number of fatal and nonfatal cerebral infarctions was 31 in the placebo (P)
group, 17 in the A group and 18 in the AD group. Taking into account the
duration of follow-up for each patient, these figures correspond to
cumulative rates of 18% in the P group and 10.5% in each of the 2 active
treatment groups. Analysis with the Mantel Method showed: 1)--A difference
at the 6% level between the 3 groups and between P and AD; 2)--A difference
at the 5% level between P and A; 3)--No difference between (A and AD; 4)--A
difference at the 2% level between the P group and the two treated groups
taken together (A + AD). Among other diseases occurring during the trial,
the only significant difference concerned myocardial infarction, which was
less frequent in the 2 treated groups (P less than 0.05). Subgroup analysis
failed to show a significant sex difference in the efficacy of aspirin. It
is concluded that, in patients comparable to those defined in the protocol,
Aspirin (1 g) has a significantly beneficial effect in the secondary
prevention of atherothrombotic cerebral infarction.
ARTICLES
"AICLA" controlled trial of aspirin and dipyridamole in the secondary prevention of athero-thrombotic cerebral ischemia
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