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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333407
Recruitment Status : Terminated (Difficulty in recruiting eligible participants)
First Posted : April 3, 2020
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 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
Actual Primary Completion Date : November 30, 2021
Actual Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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


Secondary Outcome Measures :
  1. An ordinal outcome measure of 4 levels (1 - Death, 2 - Intensive Care Unit environment, 3 - In Hospital, 4 - At Home). [ Time Frame: 30 days ]
    - In Hospital, 4 - At Home), using a Bayesian longitudinal ordinal model over 30 days

  2. Peak troponin [ Time Frame: 7- and 30- days ]
    Peak troponin within 7- and 30-days post randomization, if available.

  3. Time to discharge [ Time Frame: Up to 30 days ]
    Time to hospital discharge (length of stay)

  4. Need for non-invasive ventilatory support [ Time Frame: 30 days ]
    Need for non-invasive ventilatory support, if data available.

  5. Need for invasive ventilatory support [ Time Frame: 30 days. ]
    Need for invasive ventilatory support, if data available.

  6. Need for mechanical circulatory support [ Time Frame: 30 days ]
    Need for mechanical circulatory support, if data available.

  7. Need for renal replacement therapy [ Time Frame: 30 days ]
    Need for renal replacement therapy, if data available.

  8. Bleeding Academic Research Consortium (BARC) bleed event [ Time Frame: 30 days ]
    Bleeding Academic Research Consortium (BARC) bleed event, adjudicated

  9. Cessation of randomized active arm therapy [ Time Frame: 30 days ]
    Cessation of randomized active arm therapy


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 an acute coronary syndrome or myo-pericarditis that requires specific treatment that precludes randomization.
  2. Evidence of active bleeding
  3. Pregnancy.
  4. Age <18 years
Contacts and Locations
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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


Locations
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United Kingdom
Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Prapa Kanagaratnam, FRCP, PhD Imperial College Healthcare NHS Trust
More Information
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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: January 18, 2023
Last Verified: January 2023
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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COVID-19
Acute Coronary Syndrome
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
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