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A randomised controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalised with COVID-19: the C19-ACS trial

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Title: A randomised controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalised with COVID-19: the C19-ACS trial
Authors: Kanagaratnam, P
Francis, DP
Chamie, D
Coyle, C
Marynina, A
Katritsis, G
Paiva, P
Szigeti, M
Cole, G
De Andrade Nunes, D
Howard, J
Esper, R
Khan, M
More, R
Barreto, G
Meneguz-Moreno, R
Arnold, A
Nowbar, A
Kaura, A
Mariveles, M
March, K
Shah, J
Nijjer, S
Lip, GY
Mills, N
Camm, AJ
Cooke, GS
Corbett, SJ
Llewelyn, MJ
Ghanima, W
Toshner, M
Peters, N
Petraco, R
Al-Lamee, R
Boshoff, ASM
Durkina, M
Malik, I
Ruparelia, N
Cornelius, V
Shun-Shin, M
Item Type: Journal Article
Abstract: BACKGROUND: Patients hospitalised with COVID-19 suffer thrombotic complications. Risk factors for poor outcomes are shared with coronary artery disease. OBJECTIVES: To investigate efficacy of an acute coronary syndrome regimen in patients hospitalised with COVID-19 and coronary disease risk factors. PATIENTS/METHODS: A randomised controlled open-label trial across acute hospitals (UK and Brazil) added aspirin, clopidogrel, low-dose rivaroxaban, atorvastatin, and omeprazole to standard care for 28-days. Primary efficacy and safety outcomes were 30-day mortality and bleeding. The key secondary outcome was a daily clinical status (at home, in hospital, on intensive therapy unit admission, death). RESULTS: 320 patients from 9 centres were randomised. The trial terminated early due to low recruitment. At 30 days there was no significant difference in mortality (intervention: 11.5% vs control: 15%, unadjusted OR 0.73, 95%CI 0.38 to 1.41, p=0.355). Significant bleeds were infrequent and not significantly different between the arms (intervention: 1.9% vs control 1.9%, p>0.999). Using a Bayesian Markov longitudinal ordinal model, it was 93% probable that intervention arm participants were more likely to transition to a better clinical state each day (OR 1.46, 95% CrI 0.88 to 2.37, Pr(Beta>0)=93%; adjusted OR 1.50, 95% CrI 0.91 to 2.45, Pr(Beta>0)=95%) and median time to discharge home was two days shorter (95% CrI -4 to 0, 2% probability that it was worse). CONCLUSIONS: Acute coronary syndrome treatment regimen was associated with a reduction in the length of hospital stay without an excess in major bleeding. A larger trial is needed to evaluate mortality.
Issue Date: Aug-2023
Date of Acceptance: 29-Apr-2023
URI: http://hdl.handle.net/10044/1/104619
DOI: 10.1016/j.jtha.2023.04.045
ISSN: 1538-7836
Publisher: Elsevier
Start Page: 2213
End Page: 2222
Journal / Book Title: Journal of Thrombosis and Haemostasis
Volume: 21
Issue: 8
Copyright Statement: © 2023 Published by Elsevier Inc. on behalf of International Society on Thrombosis and Haemostasis. Copyright © 2023 The Author(s). This work is licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
Publication Status: Published
Conference Place: England
Online Publication Date: 2023-05-23
Appears in Collections:National Heart and Lung Institute
Faculty of Medicine
Imperial College London COVID-19
School of Public Health

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