Authors and Executive, and Publication Committee:Paul W. Armstrong, MD, Department of Medicine, University of Alberta, Edmonton, Alberta (Chair); Christopher B. Granger, MD, Duke University Medical Centre, Durham, NC (Vice-Chair); Peter X. Adams, MD, Alexion Pharmaceuticals, Cheshire, Conn; Christian Hamm, MD, Kerckhoff Heart Centre, Bad Nauheim, Germany; David Holmes Jr, MD, Mayo Clinic, Rochester, Minn; William W. O’Neill, MD, University of Miami, Miami, Fla; Thomas G. Todaro, MD, JD, Procter & Gamble Pharmaceuticals, Cincinnati, Ohio; Alec Vahanian, MD, Hospital Bichat, Paris, France; Frans Van de Werf, MD, PhD, Department of Cardiology, University Hospital Gathuisberg, Leuven, Belgium.
Authors and Steering Committee Members:Hussein Al-Khalidi, PhD, Procter & Gamble Pharmaceuticals, Cincinnati, Ohio; Diego Ardissino, MD, Maggiore Hospital of Parma, University of Parma, Parma, Italy; Phil Aylward, MD, PhD, FRACP, Flinders Medical Centre, Bedford Park, Australia; Amadeo Betriu, MD, Clinic Barcelona, Universitat de Barcelona, Barcelona, Spain; Judith Hochman, MD, New York University School of Medicine, New York; Kurt Huber, MD, University of Vienna, Vienna, Austria; Stefan James, MD, PhD, Uppsala University Hospital, Uppsala, Sweden; Kerry Lee, PhD, Duke Clinical Research Institute, Durham, NC; Kenneth W. Mahaffey, MD, Duke Clinical Research Institute, Durham, NC; David Moliterno, MD, Division of Cardiovascular Medicine, University of Kentucky, Lexington; Gilles Montalescot, MD, PhD, Department of Cardiology, Hôpital la Pitié-Salpétrière Institut du Coeur, Paris, France; Franz–Josef Neumann, MD, PhD, Heart Centre Bad Krozingen, Bad Krozingen, Germany; Torsten Toftegaard Nielsen, MD, PhD, Skejby University Hospital, Aarhus, Denmark; Matthias Pfisterer, MD, Department of Internal Medicine, Basel University Hospital, Basel, Switzerland; Witold Ruźyllo, MD, National Institute of Cardiology, Warsaw, Poland; Ricardo Seabra-Gomes, MD, Santa Cruz Hospital, Carnaxide, Portugal; Pierre Theroux, MD, Montreal Heart Institute, Montreal, Quebec, Canada; Arnoud van ‘t Hof, MD, Department of Cardiology, Hospital De Weezenlanden, Zwolle, the Netherlands; W. Douglas Weaver, MD, Division of Cardiology, Henry Ford Hospital, Detroit, Mich; Harvey White, MD, DSc, Auckland City Hospital, Auckland, New Zealand; Petr Widimsky, MD, PhD, Kralovske Vinohrady University Hospital, Prague, Czech Republic.
Financial Disclosures: Drs Armstrong, Granger, and Van de Werf received research grants from the trial sponsors. Members of the Steering Committee received honoraria for their participation. K. Mahaffey, has received research grants and consultant fees from Alexion Pharmaceuticals.
Author Contributions: Drs Armstrong (chair) and Granger (vice-chair) had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Armstrong, Granger, Adams, Hamm, Holmes, O’Neill, Todaro, Vahanian, Van de Werf.
Acquisition of data: Armstrong, Granger, Adams, Todaro, and the APEX Steering/Executive Committees.
Analysis and interpretation of data: Adams, Al-Khalidi, Ardissino, Armstrong, Aylward, Granger, Hamm, Hochman, Holmes, James, Lee, Mahaffey, Moliterno, Montalescot, Neumann, Seabra-Gomes, Theroux, Todaro, Vahanian, Van de Werf, Weaver, White, Widmsky.
Drafting of the manuscript: Armstrong, Granger, Al-Khalidi.
Critical revision of the manuscript for important intellectual content: APEX Steering and Executive Committees, and Mahaffey.
Statistical analysis: Al-Khalidi, Lee.
Obtained funding: Armstrong, Granger, Todaro, Adams.
Administrative, technical, or material support: Armstrong, Granger, and APEX Executive Committee.
Study supervision: Ardissino, Armstrong, Aylward, Holmes, Moliterno, Montalescot, Neumann, Nielsen, O’Neill, Pfisterer, Ruźyllo, Todaro, Vahanian, Van de Werf.
Global Operational Leadership: L. Berdan, R. Charbonneau, T. Rorick.
ARO/CRO Operations Team: C. Boyd, C. Clarey, K. Hannan, A. Holland, M. Hudson, S. Kelby, S. Kopecky, I. Kuit, B. Litwinowich, C. Reist, C. Sorbey, C. Thomas, D. Tolsma, K. Vandenberghe.
Sponsor Team: M. Holroyde, B. Johnston, K. Malloy, I. Lodhi, D. McAfee, C. Mojcik, A. Morton-Morys, S. Rollins, A. Tummon-Kamphuis, M. Van der Laan.
Medical Hotline: D. Chew, C. Granger, J. Mills, M. Patel, K. Mahaffey, P. Sinneave.
ClinicalEvents Committee: Kenneth Mahaffey (Chair), June Wampole (Lead Coordinator), Christopher O’Connor, Neal Kleiman, Eric Cohen, John French.
Data and Safety Monitoring Board: Elliott Antman (Chair), Michel Bertrand, Christoph Bode, Carl Pepine, James Ware, William Wilkinson (statistician nonvoting).
Data Coordinating Centre: Biometrics Division of Procter & Gamble, Cincinnati, Ohio, and Duke Clinical Research Institute, Durham, NC.
Funding/Support: This study was jointly funded by Procter & Gamble, Pharmaceuticals and Alexion Pharmaceuticals.
Role of the Sponsor: Procter & Gamble, Alexion Pharmaceuticals, and the Steering Committee designed the trial, developed the protocol, and determined the statistical analysis plan by consensus. Data were collected through an Internet–based electronic case-report form managed by Procter & Gamble. Procter & Gamble had query rights to the database; however, Alexion Pharmaceuticals and the steering committee had no access to the database. There were no sponsors or steering committee access to the randomization codes.
Acknowledgment: We thank the patients for their volunteer spirit and the many study coordinators, nurses, and technical and administrative staff who contributed to the APEX-AMI Study. We thank Amanda Stebbins, MS, Duke Clinical Research Institute, Durham, NC, for assistance with the replication of the primary database analysis. We thank Durenda Tremblay and Barbara Litwinowich, RN, BSN, of the University of Alberta for their excellent editorial assistance. Neither received additional compensation for their work.