ABSTRACT

I. BACKGROUND CONSENSUS II (the Cooperative New Scandinavian Enalapril Survival Study) is a trial comparing enalapril (an angiotensin converting enzyme inhibitor) and placebo in the treatment of acute myocardial infarction. The trial was designed and planned during 1989 and early 1990 and is currently (late 1990) recruiting toward a goal of 9000 patients. Although no results are yet available, in this section we describe the various procedural aspects of the trial and plans for statistical analysis, emphasizing the sequential stopping rule.