Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial. (C-19-ACS)
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|ClinicalTrials.gov Identifier: NCT04333407|
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : April 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Aspirin 75mg Drug: Clopidogrel 75mg Drug: Rivaroxaban 2.5 MG Drug: Atorvastatin 40mg Drug: Omeprazole 20mg||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3170 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective Multicentre Randomised Controlled Trial|
|Masking:||None (Open Label)|
|Official Title:||Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.|
|Actual Study Start Date :||April 3, 2020|
|Estimated Primary Completion Date :||March 30, 2021|
|Estimated Study Completion Date :||March 30, 2021|
|Experimental: Active Arm||
Drug: Aspirin 75mg
• If patient not on aspirin, add aspirin 75mg once daily unless contraindicated.
Drug: Clopidogrel 75mg
• If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated
Drug: Rivaroxaban 2.5 MG
Drug: Atorvastatin 40mg
• If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated
Drug: Omeprazole 20mg
• If patient not on a proton pump inhibitor, add omeprazole 20mg once daily.
|No Intervention: Control Arm|
- All-cause mortality at 30 days after admission [ Time Frame: at 30 days after admission ]All-cause mortality
- Absolute change in serum troponin from admission to peak value [ Time Frame: within 7 days and within 30 days of admission ]Absolute change in serum troponin from admission (or from suspicion/diagnosis of Covid-19 if already an inpatient) measurement to peak value (measured using high sensitivity troponin assay). (Phase I interim analysis)
- Discharge Rate [ Time Frame: at 7 days and 30 days after admission ]Discharge Rate: Proportion of patients discharged (or documented as medically fit for discharge)
- Intubation Rate [ Time Frame: at 7 days and at 30 days after admission ]Intubation Rate: Proportion of patients who have been intubated for mechanical ventilation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333407
|Contact: Alena Marynina, BSc, MSc||07776 email@example.com|
|Contact: Clare Coyle, BMBCh, BA, MRCP||07985 firstname.lastname@example.org|
|Charing Cross Hospital||Recruiting|
|London, United Kingdom, W6 8RF|
|Contact: Alena Marynina, BSc, MSc 07776 224520 email@example.com|
|Principal Investigator:||Prapa Kanagaratnam, FRCP, PhD||Imperial College Healthcare NHS Trust|