Question

A multicenter double-blind randomized study was carried out to compare the effect of drug X with that of a placebo in patients surviving acute myocardial infarction (AMI). Treatment with the drug started 7 days after infarction in 1,884 patients, 52% of all persons who were evaluated for entry into the study. 945 participants were randomized to treatment with drug X while 939 were assigned to the placebo group. Patients were then followed for 12 months for reinfarction. There were 152 deaths in the placebo group and 98 in the group receiving drug X.

After entry into the study, patients were first classified into three groups, those who had a previous AMI, those with a first AMI who were at high risk for other cardiovascular diseases such as congestive heart failure, and those with a first AMI who were at low risk for other cardiovascular diseases. Which term best describes the study design?

Select one:

a. Cohort study

b. Randomized clinical trial with crossover design

c. Randomized clinical trial with factorial design

d. Randomized clinical trial with stratified randomization

e. Case study design

Answer 1