Author Affiliations: Department of Cardiovascular Medicine (Drs Lauer and Topol), Cleveland Clinic Foundation, Cleveland, Ohio; and JAMA (Dr Lauer).
In 1986, the GISSI group1 published a
report of a large randomized clinical trial demonstrating that intravenous
streptokinase reduces the risk of death among patients with acute myocardial
infarction. The design of the trial was simple, as was the published report.
There was one treatment, intravenous streptokinase, whereas the control group
received no streptokinase. There was no blinding and no placebo. The end point
of interest was death from any cause during hospitalization.
Lauer MS, Topol EJ. Clinical Trials—Multiple Treatments, Multiple End Points, and Multiple Lessons. JAMA. 2003;289(19):2575–2577. doi:10.1001/jama.289.19.2575