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

Desmond G. Julian
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Desmond G. Julian: University of Newcastle-upon-Tyne

Chapter Case 27 in Data Monitoring in Clinical Trials, 2006, pp 337-345 from Springer

Abstract: 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.

Keywords: Chronic Heart Failure; Steering Committee; Percutaneous Coronary Intervention; Case Study Approach; Cardiovascular Hospitalization (search for similar items in EconPapers)
Date: 2006
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-0-387-30107-5_33

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DOI: 10.1007/0-387-30107-0_33

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