Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial. (C-19-ACS)
Primary Purpose
COVID-19
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Aspirin 75mg
Clopidogrel 75mg
Rivaroxaban 2.5 MG
Atorvastatin 40mg
Omeprazole 20mg
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus, SARS-CoV-2, COVID-19, Cardiovascular
Eligibility Criteria
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 cardiac pathology needing ACS treatment.
- Myocarditis with serum Troponin > 5000
- Bleeding risk suspected e.g. recent surgery, history of GI bleed, other abnormal blood results (Hb<10g/dl, Plts <100, any evidence of DIC)
- Study treatment may negatively impact standard best care (physician discretion).
- Unrelated co-morbidity with life expectancy <3 months.
- Pregnancy.
- Age <18 years and >85 years.
Sites / Locations
- Charing Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active Arm
Control Arm
Arm Description
Outcomes
Primary Outcome Measures
All-cause mortality
All-cause mortality
Secondary Outcome Measures
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
Peak troponin
Peak troponin within 7- and 30-days post randomization, if available.
Time to discharge
Time to hospital discharge (length of stay)
Need for non-invasive ventilatory support
Need for non-invasive ventilatory support, if data available.
Need for invasive ventilatory support
Need for invasive ventilatory support, if data available.
Need for mechanical circulatory support
Need for mechanical circulatory support, if data available.
Need for renal replacement therapy
Need for renal replacement therapy, if data available.
Bleeding Academic Research Consortium (BARC) bleed event
Bleeding Academic Research Consortium (BARC) bleed event, adjudicated
Cessation of randomized active arm therapy
Cessation of randomized active arm therapy
Full Information
NCT ID
NCT04333407
First Posted
April 1, 2020
Last Updated
January 13, 2023
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT04333407
Brief Title
Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.
Acronym
C-19-ACS
Official Title
Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting eligible participants
Study Start Date
April 3, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Coronavirus, SARS-CoV-2, COVID-19, Cardiovascular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Multicentre Randomised Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Arm
Arm Type
Experimental
Arm Title
Control Arm
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Aspirin 75mg
Intervention Description
• If patient not on aspirin, add aspirin 75mg once daily unless contraindicated.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 75mg
Intervention Description
• If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 2.5 MG
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 40mg
Intervention Description
• If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated
Intervention Type
Drug
Intervention Name(s)
Omeprazole 20mg
Intervention Description
• If patient not on a proton pump inhibitor, add omeprazole 20mg once daily.
Primary Outcome Measure Information:
Title
All-cause mortality
Description
All-cause mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
An ordinal outcome measure of 4 levels (1 - Death, 2 - Intensive Care Unit environment, 3 - In Hospital, 4 - At Home).
Description
- In Hospital, 4 - At Home), using a Bayesian longitudinal ordinal model over 30 days
Time Frame
30 days
Title
Peak troponin
Description
Peak troponin within 7- and 30-days post randomization, if available.
Time Frame
7- and 30- days
Title
Time to discharge
Description
Time to hospital discharge (length of stay)
Time Frame
Up to 30 days
Title
Need for non-invasive ventilatory support
Description
Need for non-invasive ventilatory support, if data available.
Time Frame
30 days
Title
Need for invasive ventilatory support
Description
Need for invasive ventilatory support, if data available.
Time Frame
30 days.
Title
Need for mechanical circulatory support
Description
Need for mechanical circulatory support, if data available.
Time Frame
30 days
Title
Need for renal replacement therapy
Description
Need for renal replacement therapy, if data available.
Time Frame
30 days
Title
Bleeding Academic Research Consortium (BARC) bleed event
Description
Bleeding Academic Research Consortium (BARC) bleed event, adjudicated
Time Frame
30 days
Title
Cessation of randomized active arm therapy
Description
Cessation of randomized active arm therapy
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prapa Kanagaratnam, FRCP, PhD
Organizational Affiliation
Imperial College Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared with other researchers or organisations. Anonymised data might be shared with other research organisations
Learn more about this trial
Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.
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