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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.


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.

SUBMITTER: Kanagaratnam P 

PROVIDER: S-EPMC10204350 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

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.

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

Journal of thrombosis and haemostasis : JTH 20230523 8


<h4>Background</h4>Patients hospitalized with COVID-19 suffer thrombotic complications. Risk factors for poor outcomes are shared with coronary artery disease.<h4>Objectives</h4>To investigate the efficacy of an acute coronary syndrome regimen in patients hospitalized with COVID-19 and coronary disease risk factors.<h4>Methods</h4>A randomized controlled, open-label trial across acute hospitals (United Kingdom and Brazil) added aspirin, clopidogrel, low-dose rivaroxaban, atorvastatin, and omepra  ...[more]

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