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, Christopher Appleton

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

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., ... Appleton, C. (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.; Appleton, Christopher.

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 & Appleton, C 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. ; Appleton, Christopher. / Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study. In: Stroke. 1990 ; Vol. 21, No. 4. pp. 538-545.
@article{90d86b97ec6744b8b0c6b9b5f2056705,
title = "Design of a multicenter randomized trial for the stroke prevention in atrial fibrillation study",
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.",
keywords = "Anticoagulants, Atrial, Clinical, Embolism, Fibrillation, Trials",
author = "Anderson, {David C.} and Asinger, {Richard W.} and Newburg, {Susan M.} and Farmer, {Cheryl C.} and K. Wang and Bundlie, {Scott R.} and Koller, {Richard L.} and Jagiella, {Waclav M.} and Susan Kreher and Jorgensen, {Charles R.} and Sharkey, {Scott W.} and Flaker, {Greg C.} and Richard Webel and Barbie Nolte and Pat Stevenson and John Byer and William Wright and Chesebro, {James H.} and Wiebers, {David O.} and Holland, {Anne E.} and Miller, {Diane M.} and Bardsley, {William T.} and Litin, {Scott C.} and Zerbe, {Douglas M.} and McAnulty, {John H.} and Christy Marchant and Coull, {Bruce M.} and George Feldman and Arthur Hayward and Elizabeth Gandara and Nathan Blank and Leonard, {Anne D.} and Easton, {Carann A.} and John Chanc and Easton, {J. Donald} and Kanter, {Merrill C.} and Kopecky, {Steven L.} and Isensee, {Laura M.} and Quiroga, {Elia S.} and Presti, {Charles H.} and Tegeler, {Charles H.} and Logan, {William R.} and Hamilton, {William P.} and Bacon, {Rebecca S.} and Green, {Barbara J.} and Buckingham, {Thomas A.} and Cadell, {Dorothy J.} and Gomez, {Camilo R.} and Janosik, {Denise L.} and Christopher Appleton",
year = "1990",
language = "English (US)",
volume = "21",
pages = "538--545",
journal = "Stroke",
issn = "0039-2499",
publisher = "Lippincott Williams and Wilkins",
number = "4",

}

TY - JOUR

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 - Appleton, Christopher

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

UR - http://www.scopus.com/inward/record.url?scp=0025308180&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0025308180&partnerID=8YFLogxK

M3 - Article

C2 - 2183405

AN - SCOPUS:0025308180

VL - 21

SP - 538

EP - 545

JO - Stroke

JF - Stroke

SN - 0039-2499

IS - 4

ER -