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

Prapa Kanagaratnam, Darrel P Francis, Daniel Chamie, Clare Coyle, Alena Marynina, George Katritsis, Patricia Paiva, Matyas Szigeti, Graham Cole, David de Andrade Nunes, James Howard, Rodrigo Esper, Masood Khan, Ranjit More, Guilherme Barreto, Rafael Meneguz-Moreno, Ahran Arnold, Alexandra Nowbar, Amit Kaura, Myril MarivelesKatherine March, Jaymin Shah, Sukhjinder Nijjer, Gregory Y H Lip, Nicholas Mills, A John Camm, Graham S Cooke, Simon J Corbett, Martin J Llewelyn, Waleed Ghanima, Mark Toshner, Nicholas Peters, Ricardo Petraco, Rasha Al-Lamee, Ana Sousa Marcelino Boshoff, Margarita Durkina, Iqbal Malik, Neil Ruparelia, Victoria Cornelius, Matthew Shun-Shin

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

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.

Original languageEnglish
Pages (from-to)2213-2222
Number of pages10
JournalJournal of Thrombosis and Haemostasis
Volume21
Issue number8
DOIs
Publication statusPublished - 23 May 2023

Keywords / Materials (for Non-textual outputs)

  • Humans
  • COVID-19
  • SARS-CoV-2
  • Acute Coronary Syndrome/diagnosis
  • Bayes Theorem
  • Aspirin/therapeutic use
  • Hemorrhage/chemically induced
  • Treatment Outcome

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