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Title: | Rationale and design of the colchicine for the prevention of perioperative atrial fibrillation in patients undergoing major noncardiac thoracic surgery (COP-AF) trial |
Other Titles: | Rationale and Design of COP-AF |
Authors: | Popova, Ekaterine Wang, Michael Ke Chan, Matthew T.V. Landoni, Giovanni Reimer, Cara Srinathan, Sadeesh K. Cata, Juan P. McLean, Sean R. Trujillo Reyes, Juan Carlos Martín Grande, Ascensión Gonzalez Tallada, Anna Sessler, Daniel I. Fleischmann, Edith Maziak, Donna E. Kabon, Barbara Voltolini, Luca Gutiérrez-Soriano, Laura Tandon, Vikas DuMerton, Deborah Kidane, Biniam Rajaram, Ravi Shargall, Yaron Neary, John D. Wells, Jennifer R. McIntyre, William F. Blum, Steffen Ofori, Sandra N. Vincent, Jessica Xu, Lizhen Li, Zhuoru Healey, Jeff S. Garg, Amit X. Devereaux, PJ on behalf of the COP-AF Investigators* |
Department: | Medicine |
Keywords: | Colchicine;atrial fibrillation;inflammation;myocardial injury;prevention;thoracic surgery |
Publication Date: | 7-Feb-2023 |
Publisher: | American Heart Journal |
Citation: | Conen D, Popova E, Wang MK, Chan MTV, Landoni G, Reimer C, Srinathan SK, Cata JP, McLean SR, Reyes JCT, Grande AM, Tallada AG, Sessler DI, Fleischmann E, Maziak DE, Kabon B, Voltolini L, Gutiérrez-Soriano L, Tandon V, DuMerton D, Kidane B, Rajaram R, Shargall Y, Neary JD, Wells JR, McIntyre WF, Blum S, Ofori SN, Vincent J, Xu L, Li Z, Healey JS, Garg AX, Devereaux PJ; COP-AF Investigators. Rationale and design of the colchicine for the prevention of perioperative atrial fibrillation in patients undergoing major noncardiac thoracic surgery (COP-AF) trial. Am Heart J. 2023 Feb 6:S0002-8703(23)00025-X. doi: 10.1016/j.ahj.2023.01.018. Epub ahead of print. PMID: 36754105. |
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. |
Rights: | This content is published Open Access under Creative Commons license: Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) |
URI: | http://hdl.handle.net/11375/28371 |
Identifier: | 10.1016/j.ahj.2023.01.018 |
Appears in Collections: | Medicine Publications |
Files in This Item:
File | Description | Size | Format | |
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COP-AF_Methods Paper_Final v1.0_2023-02-06.docx | 1.12 MB | Microsoft Word XML | View/Open | |
COP-AF_Methods Paper_Supplementary Appendix_Final v3.0_2023-02-22.docx | 36.47 kB | Microsoft Word XML | View/Open |
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