Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.

Study Overview
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Brief Summary
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The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. At the time of writing, there have been 150 000 confirmed cases and 3500 deaths. Apart from the morbidity and mortality directly related to COVID-19 cases, society has had to also cope with complex political and economic repercussions of this disease. At present, and despite pressing need for therapeutic intervention, management of patients with COVID-19 is entirely supportive. Despite the majority of patients experiencing a mild respiratory illness a subgroup, and in particular those with pre-existing cardiovascular disease, will experience severe illness that requires invasive cardiorespiratory support in the intensive care unit. Furthermore, the severity of COVID-19 disease (as well as the likelihood of progressing to severe disease) appears to be in part driven by direct injury to the cardiovascular system. Analysis of data from two recent studies confirms a significantly higher likelihood of acute cardiac injury in patients who have to be admitted to intensive care for the management of COVID-19 disease. The exact type of acute of cardiac injury that COVID-19 patients suffer remains unclear. There is however mounting evidence that heart attack like events are responsible. Tests ordinarily performed to definitely assess for heart attacks will not be possible in very sick COVID-19 patients. Randomising patients to cardioprotective medicines will help us understand the role of the cardiovascular system in COVID-19 disease. It will also help us determine if there is more we can do to treat these patients.

Official Title
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Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Aspirin 75mg
* Drug: Clopidogrel 75mg
* Drug: Rivaroxaban 2.5 MG
* Drug: Atorvastatin 40mg
* Drug: Omeprazole 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed COVID-19 infection Age =/>40 or diabetes or known coronary disease or hypertension Requires hospital admission for further clinical management. Exclusion Criteria: Clear evidence of an acute coronary syndrome or myo-pericarditis that requires specific treatment that precludes randomization. Evidence of active bleeding Pregnancy. Age <18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Multicentre Randomised Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Arm<br> | Drug: Aspirin 75mg<br>* • If patient not on aspirin, add aspirin 75mg once daily unless contraindicated.<br>Drug: Clopidogrel 75mg<br>* • If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated<br>Drug: Rivaroxaban 2.5 MG<br>* If patient not on an anticoagulation, add rivaroxaban 2.5mg bd unless contraindicated If patient on DOAC then change to rivaroxaban 2.5mg unless contraindicated<br>Drug: Atorvastatin 40mg<br>* • If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated<br>Drug: Omeprazole 20mg<br>* • If patient not on a proton pump inhibitor, add omeprazole 20mg once daily.<br>|
| No Intervention: Control Arm<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An ordinal outcome measure of 4 levels (1 - Death, 2 - Intensive Care Unit environment, 3 - In Hospital, 4 - At Home). | - In Hospital, 4 - At Home), using a Bayesian longitudinal ordinal model over 30 days | 30 days | 
| Peak troponin | Peak troponin within 7- and 30-days post randomization, if available. | 7- and 30- days | 
| Time to discharge | Time to hospital discharge (length of stay) | Up to 30 days | 
| Need for non-invasive ventilatory support | Need for non-invasive ventilatory support, if data available. | 30 days | 
| Need for invasive ventilatory support | Need for invasive ventilatory support, if data available. | 30 days. | 
| Need for mechanical circulatory support | Need for mechanical circulatory support, if data available. | 30 days | 
| Need for renal replacement therapy | Need for renal replacement therapy, if data available. | 30 days | 
| Bleeding Academic Research Consortium (BARC) bleed event | Bleeding Academic Research Consortium (BARC) bleed event, adjudicated | 30 days | 
| Cessation of randomized active arm therapy | Cessation of randomized active arm therapy | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus, SARS-CoV-2, COVID-19, Cardiovascular