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. Holland & 76 others Diane 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, Ileana L. 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 journalArticle

40 Citations (Scopus)

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
StatePublished - 1990
Externally publishedYes

Fingerprint

Atrial Fibrillation
Multicenter Studies
Warfarin
Stroke
Aspirin
Placebos
Prothrombin Time
Transient Ischemic Attack
Unstable Angina
Embolism
Sample Size
Randomized Controlled Trials
Myocardial Infarction
Therapeutics

Keywords

  • Anticoagulants
  • Atrial
  • Clinical
  • Embolism
  • Fibrillation
  • Trials

ASJC Scopus subject areas

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

Cite this

Anderson, D. C., Asinger, R. W., Newburg, S. M., Farmer, C. C., Wang, K., Bundlie, S. R., ... McBride, R. (1990). Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study. Stroke, 21(4), 538-545.

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

In: Stroke, Vol. 21, No. 4, 1990, p. 538-545.

Research output: Contribution to journalArticle

Anderson, DC, Asinger, RW, Newburg, SM, Farmer, CC, Wang, K, Bundlie, SR, Koller, RL, Jagiella, WM, Kreher, S, Jorgensen, CR, Sharkey, SW, Flaker, GC, Webel, R, Nolte, B, Stevenson, P, Byer, J, Wright, W, Chesebro, JH, Wiebers, DO, Holland, AE, Miller, DM, Bardsley, WT, Litin, SC, Zerbe, DM, McAnulty, JH, Marchant, C, Coull, BM, Feldman, G, Hayward, A, Gandara, E, Blank, N, Leonard, AD, Easton, CA, Chanc, J, Easton, JD, Kanter, MC, Kopecky, SL, Isensee, LM, Quiroga, ES, Presti, CH, Tegeler, CH, Logan, WR, Hamilton, WP, Bacon, RS, Green, BJ, Buckingham, TA, Cadell, DJ, Gomez, CR, Janosik, DL, Redd, RM, Labovit, AJ, Kelley, RE, Chahine, R, Cristo, L, Palermo, M, Perez, O, Pina, IL, Feinberg, WM, Void, BK, Kern, KB, Appleton, C, Miller, VT, Hockersmith, CJ, Cohen, BA, Martin, GJ, Pawlow, AJ, Halperin, JL, Rothlauf, EB, Weinberger, JM, Goldman, ME, Goldman, R, Fuster, V, Dittrich, HC, Rothrock, J, Hagenhoff, C, Helgason, CM, Kondos, GT, Kaufmann, L, Hoff, J, Rabjohns, RR, McRae, RP, Ghali, J, Adams, HP, Theilen, EO, Biller, J, Brown, DD, Marsh, EE, Sirna, SJ, Mitchell, VL, Rothbart, RM, Bailey, GH, Burkhardt, C, Horn, GV, Nacarelli, GV, Wilson, DG & McBride, R 1990, 'Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study', Stroke, vol. 21, no. 4, pp. 538-545.
Anderson DC, Asinger RW, Newburg SM, Farmer CC, Wang K, Bundlie SR et al. Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study. Stroke. 1990;21(4):538-545.
Anderson, David C. ; Asinger, Richard W. ; Newburg, Susan M. ; Farmer, Cheryl C. ; Wang, K. ; Bundlie, Scott R. ; Koller, Richard L. ; Jagiella, Waclav M. ; Kreher, Susan ; Jorgensen, Charles R. ; Sharkey, Scott W. ; Flaker, Greg C. ; Webel, Richard ; Nolte, Barbie ; Stevenson, Pat ; Byer, John ; Wright, William ; Chesebro, James H. ; Wiebers, David O. ; Holland, Anne E. ; Miller, Diane M. ; Bardsley, William T. ; Litin, Scott C. ; Zerbe, Douglas M. ; McAnulty, John H. ; Marchant, Christy ; Coull, Bruce M. ; Feldman, George ; Hayward, Arthur ; Gandara, Elizabeth ; Blank, Nathan ; Leonard, Anne D. ; Easton, Carann A. ; Chanc, John ; Easton, J. Donald ; Kanter, Merrill C. ; Kopecky, Steven L. ; Isensee, Laura M. ; Quiroga, Elia S. ; Presti, Charles H. ; Tegeler, Charles H. ; Logan, William R. ; Hamilton, William P. ; Bacon, Rebecca S. ; Green, Barbara J. ; Buckingham, Thomas A. ; Cadell, Dorothy J. ; Gomez, Camilo R. ; Janosik, Denise L. ; Redd, Robert M. ; Labovit, Arthur J. ; Kelley, Roger E. ; Chahine, Robert ; Cristo, Lillian ; Palermo, Maite ; Perez, Odalys ; Pina, Ileana L. ; Feinberg, William M. ; Void, Brenda K. ; Kern, Karl B. ; Appleton, Christopher ; Miller, Vincent T. ; Hockersmith, Connie J. ; Cohen, Bruce A. ; Martin, Gary J. ; Pawlow, Alan J. ; Halperin, Jonathan L. ; Rothlauf, Elizabeth B. ; Weinberger, Jesse M. ; Goldman, Martin E. ; Goldman, Richard ; Fuster, Valentin ; Dittrich, Howard C. ; Rothrock, Johnf ; Hagenhoff, Carol ; Helgason, Cathy M. ; Kondos, George T. ; Kaufmann, Lisa ; Hoff, Julie ; Rabjohns, R. R. ; McRae, R. P. ; Ghali, J. ; Adams, Harold P. ; Theilen, Ernest O. ; Biller, José ; Brown, Donald D. ; Marsh, Ellis Eugene ; Sirna, Sara J. ; Mitchell, Victoria L. ; Rothbart, Robert M. ; Bailey, Gretchen H. ; Burkhardt, Carolyn ; Horn, Gage Van ; Nacarelli, Gerald V. ; Wilson, Deborah Grimm ; McBride, Ruth. / Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study. In: Stroke. 1990 ; Vol. 21, No. 4. pp. 538-545.
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T1 - Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study

AU - Anderson, David C.

AU - Asinger, Richard W.

AU - Newburg, Susan M.

AU - Farmer, Cheryl C.

AU - Wang, K.

AU - Bundlie, Scott R.

AU - Koller, Richard L.

AU - Jagiella, Waclav M.

AU - Kreher, Susan

AU - Jorgensen, Charles R.

AU - Sharkey, Scott W.

AU - Flaker, Greg C.

AU - Webel, Richard

AU - Nolte, Barbie

AU - Stevenson, Pat

AU - Byer, John

AU - Wright, William

AU - Chesebro, James H.

AU - Wiebers, David O.

AU - Holland, Anne E.

AU - Miller, Diane M.

AU - Bardsley, William T.

AU - Litin, Scott C.

AU - Zerbe, Douglas M.

AU - McAnulty, John H.

AU - Marchant, Christy

AU - Coull, Bruce M.

AU - Feldman, George

AU - Hayward, Arthur

AU - Gandara, Elizabeth

AU - Blank, Nathan

AU - Leonard, Anne D.

AU - Easton, Carann A.

AU - Chanc, John

AU - Easton, J. Donald

AU - Kanter, Merrill C.

AU - Kopecky, Steven L.

AU - Isensee, Laura M.

AU - Quiroga, Elia S.

AU - Presti, Charles H.

AU - Tegeler, Charles H.

AU - Logan, William R.

AU - Hamilton, William P.

AU - Bacon, Rebecca S.

AU - Green, Barbara J.

AU - Buckingham, Thomas A.

AU - Cadell, Dorothy J.

AU - Gomez, Camilo R.

AU - Janosik, Denise L.

AU - Redd, Robert M.

AU - Labovit, Arthur J.

AU - Kelley, Roger E.

AU - Chahine, Robert

AU - Cristo, Lillian

AU - Palermo, Maite

AU - Perez, Odalys

AU - Pina, Ileana L.

AU - Feinberg, William M.

AU - Void, Brenda K.

AU - Kern, Karl B.

AU - Appleton, Christopher

AU - Miller, Vincent T.

AU - Hockersmith, Connie J.

AU - Cohen, Bruce A.

AU - Martin, Gary J.

AU - Pawlow, Alan J.

AU - Halperin, Jonathan L.

AU - Rothlauf, Elizabeth B.

AU - Weinberger, Jesse M.

AU - Goldman, Martin E.

AU - Goldman, Richard

AU - Fuster, Valentin

AU - Dittrich, Howard C.

AU - Rothrock, Johnf

AU - Hagenhoff, Carol

AU - Helgason, Cathy M.

AU - Kondos, George T.

AU - Kaufmann, Lisa

AU - Hoff, Julie

AU - Rabjohns, R. R.

AU - McRae, R. P.

AU - Ghali, J.

AU - Adams, Harold P.

AU - Theilen, Ernest O.

AU - Biller, José

AU - Brown, Donald D.

AU - Marsh, Ellis Eugene

AU - Sirna, Sara J.

AU - Mitchell, Victoria L.

AU - Rothbart, Robert M.

AU - Bailey, Gretchen H.

AU - Burkhardt, Carolyn

AU - Horn, Gage Van

AU - Nacarelli, Gerald V.

AU - Wilson, Deborah Grimm

AU - McBride, Ruth

PY - 1990

Y1 - 1990

N2 - 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.

AB - 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.

KW - Anticoagulants

KW - Atrial

KW - Clinical

KW - Embolism

KW - Fibrillation

KW - Trials

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VL - 21

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EP - 545

JO - Stroke

JF - Stroke

SN - 0039-2499

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