Drug trials in myocardial infarction. Lessons to be learned from the Anturane Reinfarction Trial.

Drug intervention trials in myocardial infarction are unlikely to prove an effect unless planning takes into consideration: (1) the multiple causes for cardiac mortality after myocardial infarction, and the likelihood that the drug being tested is unlikely to affect all of these causes; (2) the different mortality rates at different periods following the qualifying infarct; (3) the contribution of each cause to the total mortality encountered during each period; and (4) the elimination of the various dilution factors which plague those trials based only on an intention to treat rather than on the efficacy of the drug when administered properly to eligible patients. Prospective studies should be designed with these points in mind. Otherwise one will be confronted with the usual criticisms and scepticism associated with a retrospective analysis. In this regard, the Anturane Reinfarction Trial represents an advance in trial design, and the lessons to be learned from it provide a basis for further improvements.