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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

In: Data Monitoring in Clinical Trials

Author

Listed:
  • Robert G. Hart

    (University of Texas Health Science Center, Department of Medicine (Neurology))

  • Lesly A. Pearce
  • Ruth McBride

    (Axio Research Corporation)

  • Richard A. Kronmal

    (University of Washington, Department of Biostatistics)

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

Suggested Citation

  • Robert G. Hart & Lesly A. Pearce & Ruth McBride & Richard A. Kronmal, 2006. "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," Springer Books, in: David L. DeMets & Curt D. Furberg & Lawrence M. Friedman (ed.), Data Monitoring in Clinical Trials, chapter 0, pages 85-92, Springer.
    • Handle: RePEc:spr:sprchp:978-0-387-30107-5_8
    DOI: 10.1007/0-387-30107-0_8
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