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May 21, 2003

Clinical Trials—Multiple Treatments, Multiple End Points, and Multiple Lessons

Author Affiliations

Author Affiliations: Department of Cardiovascular Medicine (Drs Lauer and Topol), Cleveland Clinic Foundation, Cleveland, Ohio; and JAMA (Dr Lauer).

JAMA. 2003;289(19):2575-2577. doi:10.1001/jama.289.19.2575

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.

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