Early Termination of the Stroke Prevention in Atrial Fibrillation I Trial: Protecting Participant Interests in the Face of Scientific Uncertainties and the Cruel Play of Chance

Robert G. Hart, Lesly A. Pearce, Ruth McBride and Richard A. Kronmal
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Robert G. Hart: University of Texas Health Science Center, Department of Medicine (Neurology)
Ruth McBride: Axio Research Corporation
Richard A. Kronmal: University of Washington, Department of Biostatistics

Chapter Case 4 in Data Monitoring in Clinical Trials, 2006, pp 85-92 from Springer

Abstract: Abstract The Stroke Prevention in Atrial Fibrillation (SPAF) I trial evaluated aspirin and warfarin for prevention of stroke and nonCNS emboli in elderly patients with nonvalvular atrial fibrillation. Participants were categorized as either warfarin-eligible or warfarin-ineligible based on contraindications to or refusal of anticoagulation, and interim efficacy monitoring examined treatment effects separately by warfarin eligibility. The planned primary analyses compared aspirin to placebo among all participants and warfarin to placebo among warfarin-eligible patients. The study was terminated early following the second interim analysis due to a large reduction in thromboembolic events by aspirin versus placebo among the subgroup of warfarin-eligible participants (1 vs. 18, respectively, relative risk reduction = 94%, p

Keywords: Atrial Fibrillation; Interim Analysis; Stroke Prevention; Relative Risk Reduction; Case Study Approach (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_8

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DOI: 10.1007/0-387-30107-0_8

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