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The Data Monitoring Experience in the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction Study: Hazards of Changing Primary Outcomes

In: Data Monitoring in Clinical Trials

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  • Desmond G. Julian

    (University of Newcastle-upon-Tyne)

Abstract

The Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction (CAPRICORN) study was designed to evaluate the hypothesis that carvedilol, a beta-blocker with important differences from other beta-blockers, would be effective in reducing mortality and morbidity in post-myocardial-infarction patients with poor left ventricular function. Because of slow recruitment and a lower than expected event rate, the monitoring committee was asked to advise on a change in the primary endpoint of total mortality. This it did, but the new co-primary endpoints were negative, whereas if the original primary endpoint had been retained, the result would have been strongly positive.

Suggested Citation

  • Desmond G. Julian, 2006. "The Data Monitoring Experience in the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction Study: Hazards of Changing Primary Outcomes," Springer Books, in: David L. DeMets & Curt D. Furberg & Lawrence M. Friedman (ed.), Data Monitoring in Clinical Trials, chapter 0, pages 337-345, Springer.
    • Handle: RePEc:spr:sprchp:978-0-387-30107-5_33
    DOI: 10.1007/0-387-30107-0_33
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