- Published
- 23 May 2023
- Journal article
A randomized controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalized with COVID-19: the COVID-19 Acute Coronary Syndrome trial
- Authors
-
- Source
- Journal of Thrombosis and Haemostasis
Abstract
BACKGROUND: Patients hospitalized with COVID-19 suffer thrombotic complications. Risk factors for poor outcomes are shared with coronary artery disease.
OBJECTIVES: To investigate the efficacy of an acute coronary syndrome regimen in patients hospitalized with COVID-19 and coronary disease risk factors.
METHODS: A randomized controlled, open-label trial across acute hospitals (United Kingdom 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, or death).
RESULTS: Three hundred twenty patients from 9 centers were randomized. The trial terminated early due to low recruitment. At 30 days, there was no significant difference in mortality (intervention vs control, 11.5% vs 15%; unadjusted odds ratio [OR], 0.73; 95% CI, 0.38-1.41; p = .355). Significant bleeds were infrequent and were not significantly different between the arms (intervention vs control, 1.9% vs 1.9%; p > .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% credible interval [CrI], 0.88-2.37; Pr [beta > 0], 93%; adjusted OR, 1.50; 95% CrI, 0.91-2.45; Pr [beta > 0], 95%) and median time to discharge to home was 2 days shorter (95% CrI, -4 to 0; 2% probability that it was worse).
CONCLUSION: 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.
Cite as
Kanagaratnam, P., Francis, D., 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, G., Mills, N., Camm, A., Cooke, G., Corbett, S., Llewelyn, M., Ghanima, W., Toshner, M., Peters, N., Petraco, R., Al-Lamee, R., Boshoff, A., Durkina, M., Malik, I., Ruparelia, N., Cornelius, V. & Shun-Shin, M. 2023, 'A randomized controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalized with COVID-19: the COVID-19 Acute Coronary Syndrome trial', Journal of Thrombosis and Haemostasis, 21(8), pp. 2213-2222. https://doi.org/10.1016/j.jtha.2023.04.045