A randomized, controlled trial of aspirin in persons recovered from myocardial infarction.
The Aspirin Myocardial Infarction Study (AMIS) was a National Heart, Lung and Blood Institute-sponsored, multicenter, randomized, double-blind, and placebo-controlled trial designed to test whether the regular administration of aspirin to men and women who had experienced at least one documented myocardial infarction (MI) would result in a significant reduction in total mortality over a three-year period. Cause-specific mortality, nonfatal events, and side effects were also evaluated. Over a 13-month period, 4,524 persons between the ages of 30 and 69 years were randomized to either 1 g of aspirin per day (2,267 persons) or placebo (2,257 persons). High levels of patient compliance to study protocol were indicated by various measures. Total mortality during the entire follow-up period was 10.8% in the aspirin group and 9.7% in the placebo group. Three-year total mortality was 9.6% in the aspirin group and 8.8% in the placebo group. The percentage of definite nonfatal MI was 8.1% in the placebo group and 6.3% in the aspirin group. Coronary incidence (coronary heart disease mortality or definite nonfatal MI) was 14.1% in the aspirin group and 14.8% in the placebo group. Symptoms suggestive of peptic ulcer, gastritis, or erosion of gastric mucosa occurred in 23.7% of the aspirin group and 14.9% in the placebo group. Based on AMIS results, aspirin is not recommended for routine use in patients who have survived an MI.
D000328:Adult; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000534:rehabilitation*; D010974:Platelet Aggregation / Q000187:drug effects; D011897:Random Allocation; D012008:Recurrence; D012737:Sex Factors
D001241:Aspirin