Corresponding Author and Reprints: Philip B. Gorelick, MD, MPH, Center for Stroke Research, Rush Medical College, 1645 W Jackson, Suite 400, Chicago, IL 60612 (e-mail: [email protected]).
Author Contributions: As director of data management operations for the AAASPS, Dr Richardson had access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analyses.
Study concept and design: Gorelick, Richardson, Kelly, Harris, Leurgans.
Acquisition of data: Gorelick, Richardson, Kelly, Ruland, Hung, Harris, Kittner.
Analysis and interpretation of data: Gorelick, Richardson, Kelly, Hung, Leurgans.
Drafting of the manuscript: Gorelick, Richardson, Kelly, Harris.
Critical revision of the manuscript for important intellectual content: Gorelick, Richardson, Kelly, Ruland, Hung, Kittner, Leurgans.
Statistical expertise: Richardson, Hung, Leurgans.
Obtained funding: Gorelick, Richardson.
Administrative, technical, or material support: Gorelick, Richardson, Kelly, Ruland, Harris.
Study supervision: Gorelick, Richardson, Harris, Kittner.
AAASPS Sites (listed by recruitment for sites that randomized ≥1 enrollee, in descending order of number of enrollees): Cook County Hospital, Chicago, Ill (n = 252); principal investigator: Michael Kelly, MD; coprincipal investigator: Lafayette Singleton, MD; study coordinators: Ruby Freeman, RN, Elana Tabb. Rush-Presbyterian St Luke's Medical Center, Chicago, Ill (n = 153); principal investigators: Michael A. Sloan, MD, Michael Schneck, MD; coprincipal investigators: Gwendolyn Ford-Lynch, MD, Timothy Lukovits, MD, Sean Ruland, MD; study coordinator: Patricia Samuels, Lyesther Walker. Wayne State University, Detroit, Mich (n = 105); principal investigator: Seemant Chaturvedi, MD; coprincipal investigators: Ann Guyot, MD, Nishith Joshi, MD; study coordinators: Ellen St. Pierre, RN, Bryan Bertasio, RN, Lorraine Femino, RN, Felicia Mada, RN. Washington University, St Louis, Mo (n = 91); principal investigators: Chung Hsu, MD, PhD, Abdullah M. Nassief, MD; coprincipal investigator: John Choi, MD, PhD; study coordinators: Gerry Banet, RN, Jackie Epps-Wilbanks. Medical College of Virginia/Virginia Commonwealth University, Richmond (n = 82); principal investigator: Warren L. Felton III, MD; coprincipal investigator: John R. Taylor, MD; study coordinators: Tammy Anderson,CCRC, Kim Gitter, RN. Henry Ford Hospital, Detroit, Mich (n = 62); principal investigator: Panayiotis Mitsias, MD; coprincipal investigators: Steven Levine, MD, Nikolaos Papamitsakis, MD, Brian Silver, MD; study coordinators: Jacqueline Reuther, RN, Joyce Hargrow. Indiana University, Indianapolis (n = 53); principal investigator: Jose Biller, MD; coprincipal investigators: Askiel Bruno, MD, Linda Williams, MD, J. D. Fleck, MD, Alfredo Lopez, MD, William Jones, MD; study coordinators: Carol Kempf, RN, Alison Sears, RN, Linda Chadwick, RN. Michael Reese Hospital, Chicago, Ill (n = 50); principal investigator: Lawrence Scibilia, MD; study coordinator: Robynn Whitehead, BS. St Louis University, St Louis, Mo (n = 50); principal investigators: Salvador Cruz-Flores, MD, Daryl Thompson, MD; coprincipal investigators: Enrique Leira, MD, Rodney Leacock, MD, John Selhorst, MD; study coordinator: Eve Holzemer, RN, MSN. Hines Veterans Affairs Hospital, Hines, Ill (n = 49); principal investigator: Sudha Gupta, MD; study coordinators: Beth Scott, RN, Dawn Wetherald, RN. University of Maryland, Baltimore (n = 45); principal investigator: Marcella A. Wozniak, MD, PhD; coprincipal investigator: Steven J. Kittner, MD, MPH; study coordinators: Mary J. Sparks, RN, BSN, Mary Jo Bankard, RN, BSN, Nancy K. Zappala, RN, CDE. University of Chicago, Chicago, Ill (n = 42); principal investigator: James Brorson, MD; coprincipal investigator: Avertano Noronha, MD; study coordinator: Christi Kordeck, RN. Humana (Advocate) Health System, Chicago, Ill (n = 40); principal investigator: Jan Clark, MD; coprincipal investigator: Shahida Ahmad, MD; study coordinators: Debra Hollins, RN, Robynn Whitehead, BS. Mount Sinai Hospital, Chicago, Ill (n = 40); principal investigator: Bindu Desai, MD, Aurora Pajeau, MD, MPH; study coordinator: Robynn Whitehead, BS. University of Illinois, Chicago (n = 40); principal investigator: Cathy Helgason, MD, MLA; study coordinator: Elizabeth Brennan, RN. Louisiana State University, Shreveport (n = 34); principal investigator: Alireza Minagar, MD, Aurora Pajeau, MD, MPH; coprincipal investigator: Roger E. Kelley; study coordinator: Yan Wang, MD. Mercy Hospital, Chicago, Ill (n = 33); principal investigator: Jeffery Kramer, MD [previous principal investigator: Alan Hirsch, MD]; study coordinator: Robynn Whitehead, BS [previous study coordinator: Charlene Bermele, RN]. Drew University Los Angeles Calif (n = 31); principal investigator: George Locke, MD; coprincipal investigator: Lowell Nelson, MD, PhD; study coordinators: Ardientes Sisson, RN, Marcia Montenegro, RN. Howard University, Washington, DC (n = 31); principal investigator: Annapurni Jayam Trouth, MD; coprincipal investigator: Chitra Chari, MD; study coordinators: Shubhangi Chumble, Kolla Ratnavalli, Sonia Thomas, Sudhamayi Mokalapalli, Reena Bommasani, Elizabeth Reena Francis, Mohan Kishore Garikaparti, Adegboyega Abdulkadir. St Bernard Hospital, Chicago, Ill (n = 30); principal investigator: Elsie Walker, MD; study coordinator: Deborah Ramsey, RN. Vanderbilt University, Nashville, Tenn (n = 30); principal investigator: Howard Kirshner, MD; coprincipal investigators: Jeff Harris, MD; study coordinator: Diane Klein, RN. Lankenau Hospital, Lankenau, Pa (n = 29); principal investigator: Edgar J. Kenton III, MD; coprincipal investigators: Gary H. Friday, MD, MPH, Milton Alter, MD, PhD; study coordinators: Angela V. Whittington-Smith, Charlotte A. Baker, RN. Doctor's Hospital of Hyde Park, Chicago, Ill (n = 29); principal investigator: Elsie Walker, MD; study coordinators: Minnie Al-Mosawi, Arzola Winters. University of Virginia, Charlottesville (n = 28); principal investigator: Karen Johnston, MD; coprincipal investigator: Brad Worrall, MD; study coordinators: Gail Kongable, RN, MSN, Martha Davis, RN. Washington VA, Washington, DC (n = 27); principal investigator: Mohammad Yaseen, MD; study coordinator: Ellyce Green. University of Texas, Dallas (n = 24); principal investigator: Mark Johnson, MD; coprincipal investigators: Hal Unwin, MD, Dion Graybeal, MD; study coordinator: Jennifer Stanford, RN, MSN, CCRC. West Suburban Hospital, Oak Park, Ill (n = 24); principal investigator: John Jacobson, MD; coprincipal investigators: Madhu Soni, MD, Yvonne Curran, MD; study coordinator: Anna Treinkman, RN. St Francis Hospital, Blue Island, Ill (n = 23); principal investigator: Barry J. Riskin, MD; study coordinator: Katie Kindt, DDS. Georgia Neurology Associates, Atlanta (n = 22); principal investigator: Mark Harris, MD, study coordinators: Nancy Green, RN, Demaree Trammel, MD. University of Cincinnati, Cincinnati, Ohio (n = 21); principal investigator: Joseph P. Broderick, MD; coprincipal investigators: Daniel Woo, MD, Brett Kissela, MD; study coordinators: Colleen Rogge, RN, Kirainpal Sangha, PharmD. West Los Angeles Veterans Affairs Hospital, Los Angeles, Calif (n = 20); principal investigators: Stanley Cohen, MD, Roi Ann Wallis, MD; coprincipal investigator: Hamid Salari, MD; study coordinators: Nicole Birmingham, Dana Carmody, RN, Jonathan Wong, Kimberly Pannizon, JD. Medical College of Ohio, Toledo (n = 18); principal investigators: Gretchen Tietjen, MD, Nancy Futrell, MD; coprincipal investigator: Rima Dafer, MD; study coordinator: Andrea Korsnack, RN, CNRN. University of Texas, Houston (n = 18); principal investigators: Lewis B. Morgenstern, MD, James Grotta, MD; study coordinator: Sandi Shaw, RN. Georgetown University, Washington, DC (n = 17); principal investigators: Stanley Cohan, MD, Manuel Yepes, MD; coprincipal investigator: Heather Fitter, MD; study coordinators: Bariatu Mustapha, BSN, Kathleen Johnson, NP, Brigid Reynolds, NP. Roseland Hospital, Chicago, Ill (n = 14); principal investigator: Elsie Walker, MD; study coordinator: Robynn Whitehead, BS. Buffalo General, Buffalo, NY (n = 12); principal investigators: Richard K. T. Chan, MD, Patrick Pullicino, MD, PhD; study coordinator: Sandra Starr, RN. North General, Harlem, NY (n = 12); principal investigator: Jesse Weinberger, MD; study coordinators: Josephine Britanico, RN, MSN, Jolene Connors, RN, Lafayette Trawick, BS. Little Company of Mary Hospital, Evergreen Park, Ill (n = 12); principal investigator: Michael Schwartz, MD; study coordinator: Linda Howell, RN. Jewish Hospital, Louisville, Ky (n = 11); principal investigators: Roy J. Meckler, MD, Lynn T. Simon, MD; study coordinator: Deborah Lockridge, RN, CNRN, CCRC. Emory University, Atlanta, Ga (n = 11); principal investigator: Michael Frankel, MD; study coordinator: Janet Braimah, RN. Oklahoma City, Okla (n = 10); principal investigators: James Couch, MD, PhD, Mark Fisher, MD; study coordinator: Christina Leviston. University of Mississippi, Jackson (n = 10); principal investigators: David Lee Gordon, MD, Nathaniel Lawson, MD; coprincipal investigators: Patrick S. Reynolds, MD, Yousef Mohammad, MD; study coordinators: Greta Keys, RN, BSN, Cynthia Roach, RN, BSN. Albert Einstein College of Medicine, New York, NY (n = 7); principal investigator: Steven Sparr, MD; coprincipal investigators: Daniel Rosenbaum, MD, Paul M. Katz, MD; study coordinators: J. P. Noonan, Quinn Alfinios–Renia, RN. Mercy Hospital, Chicago, Ill (n = 7); principal investigator: Alan Hirsch, MD; study coordinator: Charlene Bermele, RN. Medical College of Georgia, Augusta (n = 6); principal investigator: Fenwick T. Nichols, III, MD; study coordinator: Mary T. Sahm, BS. Evanston Hospital, Evanston, Ill (n = 6); principal investigator: Daniel Homer, MD; study coordinator: Barbara Small, MBA, RN. Morehouse School of Medicine, Atlanta, Ga (n = 5); principal investigator: Patrick Griffith, MD; study coordinator: Gail Moss, MA. Tulane University, New Orleans, La (n = 5); principal investigator: Leon Weisberg, MD; coprincipal investigator: Dan Rodriguez, MD; study coordinators: Bee Pollock, Dawn Alonzo, RN. University of Medicine and Dentistry, Newark, NJ (n = 5); principal investigator: Andrea Hidalgo, MD; study coordinator: Doreen Monks, RN. Neurocenter, Gary, Ind (n = 5); principal investigator: Jackie Carter, MD; study coordinator: Vernita Reddix, RN. East Bay Neurology, Berkeley, Calif (n = 4); principal investigator: Brian Richardson, MD; study coordinator: Dimitri Salkovski, MD. Rochester General Hospital, Rochester, NY (n = 4); principal investigator: Joshua Hollander, MD; coprincipal investigators: Gerald W. Honch, MD; Cheryl Weber, MS, RNC, Ann M. Sass, RN. Pennsylvania Hospital, Philadelphia (n = 4); principal investigators: Dara Jamieson, MD, Brett Skolnick, PhD; study coordinator: Jennifer Nisivoccia, BS. Trinity Hospital,Chicago, Ill (n = 4); principal investigator: Shahida Ahmad, MD; study coordinator: Angela Britton. Albert Einstein College of Medicine, Philadelphia, Pa (n = 3); principal investigator: Anne Vigderman, MD; study coordinator: Connie Borschell, RN. GV Montgomery VA Medical Center, Jackson, Miss (n = 2); principal investigators: Ethel Rose, MD, Robert Herndon, MD; coprincipal investigator: Eric Undesser, MD, PhD; study coordinator: Jo Ann Chinn, RN, MSN. Olympia Fields Hospital, Olympia Fields, Ill (n = 2); principal investigator: Michael Shaenboen, DO; study coordinator: Mary Coffey, RN. St Elizabeth Hospital, Chicago, Ill (n = 2); principal investigator: David Shenker, MD; study coordinator: Jana Dillon, RN. Northwestern Memorial Hospital, Chicago, Ill (n = 1); principal investigator: Jeff Curtin, DO; study coordinators: Laura Przepiorka, RN. Medical University of South Carolina, Charleston (n = 1); principal investigator: Timothy Carter, MD; study coordinator: Elaine Tateman, RN. Neurology Associates, Harvey, Ill (n = 1); principal investigator: Tonya Fuller, MD. South Suburban Neurology Associates, Harvey, Ill (n = 1); principal investigator: Armita Bijari, MD.
Operations Committee: Philip B. Gorelick, MD, MPH (chair), DeJuran Richardson, PhD (cochair), James Brorson, MD, Sudha Gupta, MD, Cathy Helgason, MD, Chung Hsu, MD, PhD, Michael A. Kelly, MD, Michael Sloan, MD, Michael Swiontoniowski, MD, Yvonne Harris, MPA (ex-officio).
Scientific Advisory Committee: Toni Miles, MD, PhD (chair), Milton Alter, MD, PhD, Laurel Beckett, PhD, Louis R. Caplan, MD, Mark Dyken, MD, J. Donald Easton, MD, Denis Evans, MD, Robert Woolson, PhD.
Community Advisory Committee: Ethel Alexander, Minnie Al-Mosawi, Edsel Hudson, MD, Helen Hudson, Ron O'Neal, Esq, Geneva Scott, Lawrence Taylor, Arnold Turner, MD, Wayne Williamson, MD.
Inhouse Safety Committee: Maynard Cohen, MD, PhD (cochair), DeJuran Richardson, PhD (cochair), Henri Frischer, MD, PhD, Philip Liebson, MD, Greg Podraza, RN, Michael Sloan, MD, Philip B. Gorelick, MD, MPH (ex-officio), Yvonne Harris, MPA (ex-officio).
Publications Committee: Philip B. Gorelick, MD, MPH (chair), DeJuran Richardson, PhD (cochair), Jose Biller, MD, Seemant Chaturvedi, MD, Sudha Gupta, MD, Steven Kittner, MD, MPH, Sue Leurgans, PhD.
Adjudication Panel: Michael A. Kelly, MD (chair), Gwendolyn Ford-Lynch, MD, Cathy Helgason, MD, MLA, Philip Liebson, MD, Sean Ruland, DO, Michael Schneck, MD, Michael Swiontoniowski, MD.
Data Safety and Monitoring Board: Lloyd Chambless, PhD (chair), Edward Cooper, MD, Edward Feldmann, MD, Percy Karanjia, MD, Ann Lowe, MD, John Marler, MD (ex-officio, National Institutes of Health [NIH] Project Officer), Peter Gilbert, ScM (ex-officio, NIH), Barbara Radziszewska, PhD, MPH (ex-officio, NIH).
Central Laboratory: LabCorp Inc, Raritan, NJ.
Financial Management Center: Rush Medical Center, Chicago, Ill.
Clinical Management Center: Philip B. Gorelick, MD, MPH (program director), Yvonne Harris, MPA, CCRA (project manager), Onyinye Erondu, RN, Eugenia Gencheva, MD, Karen Keyes, Kelia Leach, RN, Parrish Moore, Greg Podraza, RN, Dorothy Robinson, LPN, Sean Ruland, DO, Patricia Samuels, Michael J. Schneck, MD, Michael A. Sloan, MD, Sherri Volious.
Data Management Center: DeJuran Richardson, PhD (director), Merryl Billingsley (project manager), Shande Chen, PhD, Lisa Crim, John Cursio, MS, Elena Hung, MS, Glenda Kravitz, MS, Sue Leurgans, PhD (codirector), Crystal Newkirk, Rema Raman, PhD, Vidas Simkus.
Funding/Support: This work was supported by grant RO1 NS33430 from the National Institute of Neurological Disorders and Stroke. Medications and placebos were supplied by Roche Laboratories and Bayer. Roche Laboratories and Bayer had no role beyond supplying study medications and placebos.
Acknowledgment: We acknowledge technical assistance and helpful suggestions from Rema Raman, PhD, Shande Chen, PhD, and John Cursio, MS, and helpful suggestions from Lloyd Chambless, PhD, Ann Lowe, MD, Edward Feldmann, MD, Peter Gilbert, ScD, Edward Cooper, MD, and Percy Karanjia, MD.
