Skip to main content

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

  • Chapter

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.

This is a preview of subscription content, log in via an institution.

Buying options

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   79.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   99.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Norwegian Multicentre Group. 1981. Timolol induced reduction in mortality and reinfarction in patients surviving acute myocardial infarction. N Engl J Med 304:801–807.

    Article  Google Scholar 

  2. ß-Blocker Heart Attack Trial Research Group. 1982. A randomised trial of propranolol in patients with acute myocardial infarction JAMA 247:1707–1714.

    Article  Google Scholar 

  3. Waagstein F, Hjalmarson A, Varnauskas E, Wallentin I. 1975. Effect of chronic beta-adrenergic receptor blockade in congestive cardiomyopathy. Br Heart J 37:1022–1023.

    Article  Google Scholar 

  4. Dargie HJ on behalf of the CAPRICORN Investigators. 2000. Design and methodology of the CAPRICORN trial-a randomised double blind placebo controlled study of the impact of carvedilol on morbidity and mortality in patients with left ventricular dysfunction after myocardial infarction. Eur J Heart Fail 2:325–332.

    Article  Google Scholar 

  5. CIBIS-II Investigators. 1999. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): A randomised trial. Lancet 353:9–13.

    Article  Google Scholar 

  6. MERIT-HF Study Group. 1999. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF) Lancet 353:2001–2007.

    Article  Google Scholar 

  7. CAPRICORN Investigators. 2001. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction:The CAPRICORN randomised trial. Lancet 357:1385–1390.

    Article  Google Scholar 

  8. Packer M, Fowler MB, Roecker EB, Coats AJ, Katus HA, Krum H, et al. 2002. Effect of carvedilol on the morbidity of patients with severe chronic heart failure: Results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study. Circulation 106:2194–2199.

    Article  Google Scholar 

  9. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Cardiovascular and Renal Drugs Advisory Committee, 98th Meeting, January 7, 2003. www.fda.gov/ohrms/dockets/ac/03/transcripts/3920T2.htm

    Google Scholar 

  10. Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, et al. 2003. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med 348:1309–1321.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2006 Springer Science+Business Media, Inc.

About this chapter

Cite this chapter

Julian, D.G. (2006). The Data Monitoring Experience in the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction Study: Hazards of Changing Primary Outcomes. In: DeMets, D.L., Furberg, C.D., Friedman, L.M. (eds) Data Monitoring in Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/0-387-30107-0_33

Download citation

Publish with us

Policies and ethics