Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study

David C. Anderson, Richard W. Asinger, Susan M. Newburg, Cheryl C. Farmer, K. Wang, Scott R. Bundlie, Richard L. Koller, Waclav M. Jagiella, Susan Kreher, Charles R. Jorgensen, Scott W. Sharkey, Greg C. Flaker, Richard Webel, Barbie Nolte, Pat Stevenson, John Byer, William Wright, James H. Chesebro, David O. Wiebers, Anne E. HollandDiane M. Miller, William T. Bardsley, Scott C. Litin, Douglas M. Zerbe, John H. McAnulty, Christy Marchant, Bruce M. Coull, George Feldman, Arthur Hayward, Elizabeth Gandara, Nathan Blank, Anne D. Leonard, Carann A. Easton, John Chanc, J. Donald Easton, Merrill C. Kanter, Steven L. Kopecky, Laura M. Isensee, Elia S. Quiroga, Charles H. Presti, Charles H. Tegeler, William R. Logan, William P. Hamilton, Rebecca S. Bacon, Barbara J. Green, Thomas A. Buckingham, Dorothy J. Cadell, Camilo R. Gomez, Denise L. Janosik, Robert M. Redd, Arthur J. Labovit, Roger E. Kelley, Robert Chahine, Lillian Cristo, Maite Palermo, Odalys Perez, Iliana Pina, William M. Feinberg, Brenda K. Void, Karl B. Kern, Christopher Appleton, Vincent T. Miller, Connie J. Hockersmith, Bruce A. Cohen, Gary J. Martin, Alan J. Pawlow, Jonathan L. Halperin, Elizabeth B. Rothlauf, Jesse M. Weinberger, Martin E. Goldman, Richard Goldman, Valentin Fuster, Howard C. Dittrich, Johnf Rothrock, Carol Hagenhoff, Cathy M. Helgason, George T. Kondos, Lisa Kaufmann, Julie Hoff, R. R. Rabjohns, R. P. McRae, J. Ghali, Harold P. Adams, Ernest O. Theilen, José Biller, Donald D. Brown, Ellis Eugene Marsh, Sara J. Sirna, Victoria L. Mitchell, Robert M. Rothbart, Gretchen H. Bailey, Carolyn Burkhardt, Gage Van Horn, Gerald V. Nacarelli, Deborah Grimm Wilson, Ruth McBride

Research output: Contribution to journalArticlepeer-review

41 Scopus citations

Abstract

Individuals with nonvalvular atrial fibrillation are at Increased risk of stroke. The Stroke Prevention in Atrial Fibrillation Study is a 15-center randomized clinical trial examining the risks and benefits of low-intensity warfarin (prothrombin time of 1.3-1.8 times control) and aspirin (325 mg/day) in patients with constant or intermittent atrial fibrillation. Candidates for anticoagulation (group I) are randomized to receive warfarin in an open-label fashion, aspirin, or placebo; the last two treatments are given in a double-blind fashion. Warfarin-ineligible patients (group II) are randomized to receive aspirin or placebo in a double-blind fashion. Primary end points are ischemic stroke and systemic embolism. Secondary end points are death, transient ischemic attack, myocardial infarction, and unstable angina pectoris. Analysis is based on the intention-to-treat principle. The anticipated rate of primary end points in patients receiving placebo is 6%/yr. The sample size of 1,644 patients is based on a projected reduction in the rate of primary end points of 50% by warfarin and of 33% by aspirin (β=03, or=0.05). Patient entry commenced in June 1987 and will continue for 3 years, with an additional year of follow-up. High-risk subsamples identified by clinical and echocardiographic criteria are sought prospectively.

Original languageEnglish (US)
Pages (from-to)538-545
Number of pages8
JournalStroke
Volume21
Issue number4
DOIs
StatePublished - Apr 1990

All Science Journal Classification (ASJC) codes

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

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