CLINICAL IMPLICATIONS • Given no overall benefit of warfar<strong>in</strong> and <strong>in</strong>creased risk of bleed<strong>in</strong>g, <strong>in</strong> spite of suggestive benefit at 4 years and beyond, there is no compell<strong>in</strong>g evidence to use warfar<strong>in</strong> or aspir<strong>in</strong> for all patients. • Given effectiveness <strong>in</strong> prevent<strong>in</strong>g stroke, and possible benefit of warfar<strong>in</strong> after 4 years, analyses be<strong>in</strong>g performed to identify groups that will benefit from warfar<strong>in</strong> or aspir<strong>in</strong>.
STUDY ORGANIZATION Sponsor – the National Institute of Neurological Disorders and Stroke.U01-NS-043975 (S. Homma), and U01-NS-039143 (J.L.P. Thompson) Executive Committee – S. Homma, J.L.P Thompson, P. Pullic<strong>in</strong>o, R. Freudenberger, S. Graham, J. Teerl<strong>in</strong>k, S. Ammon, D. Mann, J.P. Mohr, R.L. Sacco, B. Massie, S. Anker, A. Labovitz, and C. Moy (NIH project scientist) Cl<strong>in</strong>ical Coord<strong>in</strong>at<strong>in</strong>g Center – S. Homma,V. Mejia, A. Gabriel, S. Borden, E. Peña, C. Harris, R. Khadouri, D. Gohs, M. Brown, G. Berry, D. Disantis, M. Scull<strong>in</strong>, P. Smith, S. Kohsaka, W. Watson, and L. Guillory. Statistical Analysis Center – J. L. P. Thompson, B. Lev<strong>in</strong>, R. Buchsbaum, M. Del Valle, A. Sanford, G. Levy, K. Tea, J. Grier, L. Swydan, B. O’Hare, R. Prodhan, R. Arb<strong>in</strong>g, E. Flanagan, E. Duverger, A. Peljto, W. Lo, A. Tierney, A. Henriquez, and J. Keen. CEC – J.R. Teerl<strong>in</strong>k, S. Ammon, S. Slomiak, and L. Cape. Neurology Adjudicators – H.J.M. Barnett, A. Bruno, J.D. Easton, S. Lev<strong>in</strong>e, and D. Sahlas; Cardiology Adjudicators – F. Bleyer, P. Carson, A. Ellis, A. Miller, and S.T. Palmeri; Hemorrhage adjudicator – R. Hart. Core Echo Lab: A. Labovitz, M. Di Tullio, M.Bierig, R. Liu, and C. Donato. DSMB – G.J. del Zoppo, G.W. Albers, M. Eliasziw, J.A. H<strong>in</strong>chey, K.C. Johnston, A.M. Lowe, I.L. Piña, J.A. Swa<strong>in</strong>, and P. Gilbert (NIH liaison)