Abstract
Between September 1985 and June 1987, five clinical trials were initiated to evaluate the use of warfarin to prevent stroke in patients with nonrheumatic, non-valvular atrial fibrillation. They were similar in terms of study population and primary outcome, but differed in their International Normalized Ratio (INR) goals. The first three trials, all terminated early between January 1989 and November 1990, reported marked reductions in embolic complications with warfarin. As a consequence, the remaining trials were terminated ahead of schedule, primarily for ethical reasons. Publication of results from similar trials can influence ongoing trials, potentially closing the “ethical” window of opportunity by withholding proven beneficial treatment.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Feinberg WM, Blackshear JL, Laupacis A, Kronmal R, Hart RG. 1995. Prevalence, age distribution, and gender of patients with atrial fibrillation. Analysis and implications. Arch Intern Med 155:469–473.
Furberg CD, Psaty BM, Manolio TA, Gardin JM, Smith VE, Rautaharju PM. 1994. Prevalence of atrial fibrillation in elderly subjects (The Cardiovascular Health Study). Am J Cardiol 74:236–241.
Quality Standards Subcommittee of the American Academy of Neurology. 1998. Practice Parameter: Stroke Prevention in Patients with Nonvalvular Atrial Fibrillation. Neurology 51:671–673.
Petersen P, Boysen G, Godtfredsen J, Andersen ED, Andersen B. 1989. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet 1:175–179.
Special Report: preliminary report of the Stroke Prevention in Atrial Fibrillation study. 1990. N Engl J Med 322:863–868.
Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. 1990. The effect of low dose warfarin on the risk of stroke in non-rheumatic atrial fibrillation. N Engl J Med 323:1505–1511.
Connolly SJ, Laupacis A, Gent M, Roberts RS, Cairns JA, Joyner C. 1991. Canadian Atrial Fibrillation Anticoagulation (CAFA) Study. J Am Coll Cardiology 18(2):349–355.
Ezekowitz MD, Bridgers SL, James KE, Carliner NH, Colling CL, Gornick CC, et al. 1992. Warfarin in the prevention of stroke associated with nonrheumatic atrial fibrillation. Veterans Affairs Stroke Prevention in Nonrheumatic Atrial Fibrillation Investigators. N Engl J Med 327(20):1406–1412.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2006 Springer Science+Business Media, Inc.
About this chapter
Cite this chapter
Tegeler, C.H., Furberg, C.D. (2006). Lessons From Warfarin Trials in Atrial Fibrillation: Missing the Window of Opportunity. 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_30
Download citation
DOI: https://doi.org/10.1007/0-387-30107-0_30
Publisher Name: Springer, New York, NY
Print ISBN: 978-0-387-20330-0
Online ISBN: 978-0-387-30107-5
eBook Packages: Mathematics and StatisticsMathematics and Statistics (R0)