Author Contributions: Drs Díaz, Goyal, and Yusuf 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. Drs Díaz and Goyal contributed equally and are joint first authors.
Study concept and design: Díaz, Goyal, Mehta, Xavier, Pais, Zhu, Liu, Budaj, Yusuf.
Acquisition of data: Díaz, Mehta, Xavier, Pais, Chrolavicius, Zhu, Kazmi, Liu, Budaj, Zubaid, Avezum, Ruda.
Analysis and interpretation of data: Díaz, Goyal, Mehta, Afzal, Yusuf.
Drafting of the manuscript: Díaz, Goyal, Afzal, Yusuf.
Critical revision of the manuscript for important intellectual content: Mehta, Xavier, Pais, Chrolavicius, Zhu, Kazmi, Liu, Budaj, Zubaid, Avezum, Ruda, Yusuf.
Statistical analysis: Goyal, Afzal.
Obtained funding: Díaz, Mehta, Yusuf.
Administrative, technical, or material support: Mehta, Xavier, Pais, Chrolavicius, Zhu, Kazmi, Liu, Budaj, Zubaid, Avezum, Ruda.
Study supervision: Díaz, Mehta, Xavier, Pais, Chrolavicius, Zhu, Kazmi, Liu, Budaj, Zubaid, Avezum, Ruda, Yusuf.
Financial Disclosures: Dr Mehta reported serving as a consultant for and on the speaker's bureau of Sanofi-Aventis and GlaxoSmithKline. Dr Budaj reported serving on the advisory board for and receiving honoraria for lectures from Sanofi-Aventis and GlaxoSmithKline. Dr Yusuf reported receiving honoraria for lectures, serving as a consultant for, and receiving research grants from Sanofi-Aventis and GlaxoSmithKline. No other authors reported financial disclosures.
Funding/Support: The OASIS-6 trial was jointly funded by Sanofi-Aventis, Organon, and GlaxoSmithKline.
Role of the Sponsor: The sponsors of the OASIS-6 trial had no role in the statistical analysis or data interpretation of the study, or in the preparation, review, or approval of the manuscript. Both trials were conducted independently by their respective steering committees and the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario. No direct compensation was received by these individuals.
Operations Committee of the OASIS-6 GIK Trial: S. Yusuf (principal investigator and chairman), S. R. Mehta (project director), J. P. Bassand, A. Budaj, S. Chrolavicius (project manager), K. A. A. Fox (co-chairman), C. B. Granger, C. Joyner, R. J. G. Peters, L. Wallentin.
Steering Committee of the OASIS-6 GIK Trial: A. Avezum, W. Boden, E. Cardona-Muñoz, L. Ceremuzynski, J. Col, P. J. Commerford, R. Diaz, D. Faxon, M. Flather, G. Fodor, M-G. Franzosi, C. Granger, D. Halon, D. Hunt, N. Karatzas, M. Keltai, M. Kenda, J-H. Kim, F. Lanas, C. P. Lau, B. Lewis, L. Lisheng, J. Morais, T. Moccetti, E. Paolasso, A. Parkhomenko, B. Petrauskiene, L. Piegas, T. Pipilis, D. Robaayah, M. Ruda, Z. Rumboldt, H-J. Rupprecht, E. Sitkei, P. G. Steg, E. Swahn, P. Theroux, V. Valentin, J. Varigos, J. Weitz, H. White, P. Widimsky, D. Xavier, J. Zhu, and members of the Operations Committee.
Adjudication Committee of the OASIS-6 GIK Trial: C. Joyner (committee chair), S. Ameriso, E. Anev, A. Avezum, E. C. Bonilla, E. Cardona-Muñoz, Y. K. Chan, W-H. Chen, E. A. Cohen, P. J. Commerford, Y. Cottin, A. Czepiel, H. De Raedt, R. Diaz, J. Eikelboom, G. Fodor, E. Gardinale, P. Gregor, M. Heras, D. Hunt, O. Irkin, S. S. Iyengar, P. Kalvach, N. Karatzas, M. Keltai, A. Komarov, C. P. Lau, E. Lundstrom, I. Lusic, Y. Lutay, A. P. Maggioni, A. Massaro, B. M. Mayosi, J. Morais, J. Narendra, E. Paolasso, A. Parkhomenko, A. Peeters, M. Penicka, A. Perakis, B. Petrauskiene, L. Piegas, S. Polic, S. Radhakrishnan, J. Renkin, Z. Rumboldt, E. Sitkei, I. Staikov, P. G. Steg, B. Stockins, K. Thygesen, V. Valentin, W. Wasek, P. Widimsky, Y. Yotov, J. Zaborski, J. Zhu.
Project Office: B. Meeks, J. Willcox, C. Horsman (coordinators), R. Afzal, J. Pogue (statisticians), N. Barr, S. Boccalon, B. Cracknell, K. Chrysler, A. Djuric, C. Easton, T. Gracie, T. Hoskin, B. Jedrzejowski, J. Johnson, M. Lawrence, R. Napoleoni, M. Smiley, C. Stevens.
Medical Help Line: S. Connolly, C. Demers, P. J. Devereaux, J. Healey, E. Lonn, P. Magloire, R. McKelvie, C. Morillo, M. Natarajan, M. Rokoss, K. Teo, N. Valettas, J. Velianou.
Data and Safety Monitoring Board: P. Sleight (chairman), J. L. Anderson, D. E. Johnstone, J. Hirsh, D. deMets, D. R. Holmes Jr.
Investigators Enrolling at Least 5 Patients in the OASIS-6 GIK Trial:Argentina (179 enrolled): A. Ahuad Guerrero, J. P. Albisu, J. J. Bluguermann, A. Caccavo, L. Cartasegna, R. Castellanos, C. Cuneo, E. G. Hasbani, M. Hominal, R. Kevorkian, H. L. Luciardi, E. M. Marzetti, R. Nordaby, A. Orlandini, M. Osvaldo, H. Ramos. Australia (49 enrolled): F. Nelson, J. Waites, R. Ziffer. Belgium (79 enrolled): J. Col, C. Convens, P. Coussement, D. El Allaf, R. Popeye, M. Vrolix. Brazil (286 enrolled): J. A. Abrantes, D. Campos de Albuquerque, A. C. C. Carvalho, M. Coutinho, R. D’Aurea Mora Jr, L. R. de Ataide Castro, O. Dutra, M. Esteves Hernandez, E. R. Fernandez Manenti, G. V. Greque, C. Gun, J. F. Kerr Saraiva, C. Polanczyk, A. Rabelo Jr, R. F. Ramos, P. R. F. Rossi, M. Silveira Teixeira. Bulgaria (89 enrolled): B. Chompalova, V. Hergeldjieva, A. Penev, I. Perchev, A. L. Popov, D. Raev G. Todorov, M. Tzekova. Canada (17 enrolled): S. Brons, J. Webb. Chile (35 enrolled): P. Castro, C. Conejeros, F. Lanas. Croatia (46 enrolled): M. Bergovec, M. Padovan, S. Polić. Czech Republic (199 enrolled): M. Branny, P. Červinka, A. Herman, F. Holm, P. Jansky, P. Jelínek, R. Jirmar, P. Kala, R. Stipal, M. Zelizko. Estonia (33 enrolled): Y. Soopõld. France (29 enrolled): B. Charbonnier, P. Legalery. Germany (29 enrolled): T. M. Muenzel. India (181 enrolled): C. Asokan Nambiar, A. Bharani, N. Chidambaran, V. Dayasagar Rao, J. Joseph, P. G. Kerbar, P. Kumar, S. Kumar Trivedi, A. Mathur, P. P. Mohanan, J. Narenda, R. B. Panwar, K. H. Parikh, K. Pradeep Kumar, P. Rajendra Kumar, P. Ramesh Babu, S. Sanghvi, S. Thanikachalam, R. K. Tongia. Italy (31 enrolled): M. Lettino, G. Marenzi. Latvia (12 enrolled): A. Erglis, J. Verbovenko. Lithuania (16 enrolled): B. Petrauskiene, R. Zaliunas. Mexico (44 enrolled): E. Cardona-Munoz, R. Gonzalez-Garcia, H. Hernandez-Garcia, E. Uruchurtu-Chavarin. Netherlands (90 enrolled): A. E. R. Arnold, J. P. R. Herrman, H. Suryapranata, M. W. J. van Hessen. New Zealand (54 enrolled): G. P. Devlin, H. Hart, M. Williams. Poland (230 enrolled): P. Achremczyk, P. Buszman, M. Dalkowski, H. Halaczkiewicz, A. Kleinrok, W. Krasowski, Z. Miastkowski, F. Monies, W. Pluta, T. Siminiak, R. Szelemej, M. Szpajer, M. Trusz-Gluza, A. Wester, J. Wodniecki. Romania (35 enrolled): P. Ionescu, C. Olariu. Russia (491 enrolled): G. Aroutiounov, O. Azarin, Y. Belousov, I. N. Bokarev, S. Bondarev, M. V. Boyarkin, R. Charchoglian, P. Y. Dovgalevsky, L. Egorova, B. M. Goloshchekin, A. Gruzdev, V. T. Ivashkin, Y. B. Karpov, O. A. Khrusalev, V. A. Lusov, V. A. Markov, V. Mkrtchian, V. Moiseev, Y. U. Nikitin, A. Panov, S. Schalaev, Y. S. Titkov, E. Vasilieva, A. Vishnevsky, V. Zadionchenko, D. Zateyshchikov, E. Zemtsovky. Slovakia (13 enrolled): P. Poliacik. Slovenia (19 enrolled): Z. Pehnec, G. Voga. South Africa (61 enrolled): H. du Toit Theron, J. M. Engelbrecht, G. Meintjies, M. Ntsekhe, M. Pretorius. Spain (186 enrolled): J. L. Carpintero Avellaneda, R. Coma Samartin, A. del Castillo, M. Fiol Sala, M. Heras, V. López García-Aranda, C. Macaya, R. Porcar, A. Rodriguez Llorian. Sweden (36 enrolled): M. Lycksell, J. Oldgren, A. Stjerna, E. Swahn. Switzerland (17 enrolled): T. Moccetti, M. Pieper. Ukraine (94 enrolled): O. I. Karpenko, Y. M. Kolchin, L. Kononenko, O. Kova, I. Kovalsky, A. V. Lehkonogov, Y. V. Malinovky, V. Netiazhenko, A. Parkhomenko, V. Tseluyko, N. T. Vatutin. United Kingdom (29 enrolled): P. J. Keeling. United States (6 enrolled): E. Rivera.
Previous Presentation: The primary results of the CREATE-ECLA GIK trial and the fondaparinux factorial of the OASIS-6 trial have been previously published in JAMA.5- 6 However, all data in this manuscript are original and have not been previously published.
Additional Contributions: We are grateful to the patients for agreeing to participate in the trials, and to Judy Lindeman, BA (Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario), for secretarial assistance. Ms Lindeman did not receive any additional compensation for her work on the manuscript.