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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333407
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Multicentre Randomised Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
  • 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

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



Primary Outcome Measures :
  1. All-cause mortality at 30 days after admission [ Time Frame: at 30 days after admission ]
    All-cause mortality


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed COVID-19 infection
  2. Age =/>40 or diabetes or known coronary disease or hypertension
  3. Requires hospital admission for further clinical management.

Exclusion Criteria:

  1. Clear evidence of cardiac pathology needing ACS treatment.
  2. Myocarditis with serum Troponin > 5000
  3. Bleeding risk suspected e.g. recent surgery, history of GI bleed, other abnormal blood results (Hb<10g/dl, Plts <100, any evidence of DIC)
  4. Study treatment may negatively impact standard best care (physician discretion).
  5. Unrelated co-morbidity with life expectancy <3 months.
  6. Pregnancy.
  7. Age <18 years and >85 years.

Information from the National Library of Medicine

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


Contacts
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Contact: Alena Marynina, BSc, MSc 07776 224520 alena.marynina@nhs.net
Contact: Clare Coyle, BMBCh, BA, MRCP 07985 352148 c.coyle@imperial.ac.uk

Locations
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United Kingdom
Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Contact: Alena Marynina, BSc, MSc    07776 224520    alena.marynina@nhs.net   
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Prapa Kanagaratnam, FRCP, PhD Imperial College Healthcare NHS Trust
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04333407    
Other Study ID Numbers: 20HH5868
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared with other researchers or organisations. Anonymised data might be shared with other research organisations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Coronavirus, SARS-CoV-2, COVID-19, Cardiovascular
Additional relevant MeSH terms:
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Anticoagulants
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Omeprazole
Rivaroxaban
Clopidogrel
Atorvastatin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents