1. Rationale and design of the colchicine for the prevention of perioperative atrial fibrillation in patients undergoing major noncardiac thoracic surgery (COP-AF) trial
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David Conen, Ekaterine Popova, Michael Ke Wang, Matthew T.V. Chan, Giovanni Landoni, Cara Reimer, Sadeesh K. Srinathan, Juan P. Cata, Sean R. McLean, Juan Carlos Trujillo Reyes, Ascensión Martín Grande, Anna Gonzalez Tallada, Daniel I. Sessler, Edith Fleischmann, Donna E. Maziak, Barbara Kabon, Luca Voltolini, Laura Gutiérrez-Soriano, Vikas Tandon, Deborah DuMerton, Biniam Kidane, Ravi Rajaram, Yaron Shargall, John D. Neary, Jennifer R. Wells, William F. McIntyre, Steffen Blum, Sandra N. Ofori, Jessica Vincent, Lizhen Xu, Zhuoru Li, Jeff S. Healey, Amit X. Garg, PJ Devereaux, null Devereaux, Mohammed Amir, Shrikant I. Bangdiwala, Matthias Bossard, John W. Eikelboom, Sanjit S. Jolly, Felix Ramón Montes, Denis Schmartz, Chew Yin Wang, Jesus Alvarez-Garcia, Giuliana Lo Bianco, Danielle de Sa Boasquevisque, Flavia K. Borges, Helene Chiarella-Redfern, Aranzazu Gonzalez-Osuna, Jose M. Guerra-Ramos, Maura Marcucci, Pascal B. Meyre, Christopher Oleynick, Anna Ramos-Pachón, Hugh Traquair, L. Brent Mitchell, George Wyse, Davy Cheng, Finlay A. McAlister, George A. Wells, Geethan Baskaran, Julia Gennaccaro, Rosemary Howe, Louise Mastrangelo, Shirley Pettit, Subana Shahbaz, Makayla Tosh, Simona J. Zucchetto, Laura Heenan, Shun Fu Lee, Christian Reiterer, Alexander Taschner, Katharina Horvath, Nikolas Adamowitsch, Oliver Zotti, Nicole Hantáková, Beatrix Hochreiter, Isabelle Huybrechts, Serge Cappeliez, Christian Finley, John Agzarian, Waël Hanna, Muammar Abdulrahman, Kelly Lawrence, Krysten Gregus, Faraaz Quraishi, Spencer Wikkerink, Christine Wallace, Merissa Prine, Emily Gregus, Jacqueline Hare, Kristen Lombardo, Behashta Fezia, Teresa Columbus, Ken Reid, Joel Parlow, Wiley Chung, Maria Karizhenskaia, Aftab Malik, Richard Liu, Lawrence Tan, Stephen Gowing, Gordon Buduhan, Stephanie Enns, Emma Poole, Kristin Graham, Anna McGuire, Jens Lohser, Shirley Lim, Rebecca Grey, Kyle Grant, Alex L. Lee, James J. Choi, Leith R. Dewar, John Yee, Andrew J.E. Seely, Sebastien Gilbert, P. James Villeneuve, Sudhir Sundaresan, Susan D. Moffatt-Bruce, Molly Gingrich, Anna Fazekas, Kirby Bucciero, Richard A. Malthaner, Deb Lewis, Dalilah Fortin, Mehdi Qiabi, Rahul Nayak, Madelaine Marie Plourde, Daniel Sellers, Laura Donahoe, Marco Lefebvre, Luc Lanthier, Colin Schieman, Amal Bessissow, Gavin M. Joynt, Randolph H.L. Wong, Rainbow W.H. Lau, Wai Tat Wong, Gordon Y.S. Choi, Eva Lee, Ka Yan Hui, Beaker Fung, Chee Sam Chan, Laura Carmenza Castañeda, Luis Jaime Téllez, Lina Marcela Ortiz-Ramirez, Simona De Santis, Giovanni Favaro, Piergiorgio Muriana, Cristina Nakhnoukh, Pierluigi Novellis, Stefano Turi, Giulia Veronesi, Matteo Angelini, Stefano Bongiolatti, Alberto Salvicchi, Lavinia Gatteschi, Rossella Indino, Simone Tombelli, Alice Ravasin, Ottavia Salimbene, Giulio Luca Rosboch, Eleonora Balzani, Domenico Massullo, Silvia Fiorelli, Francesco Londero, William Grossi, Tyng Yan Ng, Woan Shiang See, Mohammed Asghar Nawaz, Elisabeth Martinez Tellez, Josep Belda Sanchis, Georgina Planas Cánovas, Ana Parera Ruiz, Esther Cladellas Gutierrez, Mauro Guarino, Gerard Urrutia Cuchi, Marta Argilaga Nogues, Anna Rovira Juan, Melixa Medina-Aedo, Diego Parise Roux, Luis Gajate Martín, Angélica De Pablo Pajares, Angel Manuel Candela Toha, Nicolás Moreno Mata, Gema Muñoz Molina, Usue Caballero Silva, Alberto Cabañero, Sara Fra Fernandez, Anna Gonzàlez Tallada, Susana González Suarez, Montserrat Ribas Ball, Miriam De Nadal Clanchet, Laura Ruiz-Villa, M.M. Martí-Ejarque, Mireia Gili-Bueno, Jorge Hernández Ferrández, Neus Pons Llobet, Patricia Cruz, Guillermo Sánchez-Pedrosa, Patricia Duque, Leire Azcárate, Lorena Martín-Albo, Alberto Rodríguez-Fuster, Silvia Bermejo-Martínez, Albert Carramiñana, Fabrizio Minervini, German Corrales, Juan Jose Guerra-Londono, Reza Mehran, Boris Sepesi, Garrett Walsh, Daniel S. Cukierman, Bryan E. Marchant, Lynne C. Harris, Bruce D. Cusson, Scott A. Miller, Steven C. Minear, Camila Teixeira, Mario Pimentel, Andrew M. Popoff, Wing Lee Cheung, Kelly Marsack, Sabry Ayad, Jorge Araujo, Tzonghuei H. Chen, Michael Essandoh, Jeremy S. Poppers, and Medicine
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prevention ,inflammation ,atrial fibrillation ,myocardial injury ,Colchicine ,Cardiology and Cardiovascular Medicine ,thoracic surgery - Abstract
Background: Perioperative atrial fibrillation (AF) and myocardial injury after noncardiac surgery (MINS) are common complications after noncardiac surgery. Inflammation has been implicated in the pathogenesis of both disorders. The COP-AF trial tests the hypothesis that colchicine reduces the incidence of perioperative AF and MINS in patients undergoing major noncardiac thoracic surgery. Design: The 'COlchicine for the Prevention of Perioperative Atrial Fibrillation' (COP-AF) trial is an international, blinded, randomized trial that compares colchicine to placebo in patients aged at least 55 years and undergoing major noncardiac thoracic surgery with general anesthesia. Exclusion criteria include a history of AF and a contraindication to colchicine (e.g., severe renal dysfunction). Oral colchicine at a dose of 0.5 mg or matching placebo is given within 4 hours before surgery. Thereafter, patients receive colchicine 0.5 mg or placebo twice daily for a total of 10 days. The two independent co-primary outcomes are clinically important perioperative AF (including atrial flutter) and MINS during 14 days of follow-up. The main safety outcomes are sepsis or infection and non-infectious diarrhea. We aim to enroll 3,200 patients from approximately 40 sites across 11 countries to have at least 80% power for the independent evaluation of the two co-primary outcomes. Summary: COP-AF is a large randomized and blinded trial designed to determine whether colchicine reduces the risk of perioperative AF or MINS in patients who have major noncardiac thoracic surgery. Population Health Research Institute
- Published
- 2023
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