COVID-19C-19-ACSNCT04333407
Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.
A study testing Aspirin 75mg, Clopidogrel 75mg and Rivaroxaban 2.5 MG in people with COVID-19, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Aspirin 75mg, Clopidogrel 75mg and Rivaroxaban 2.5 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed COVID-19 infection
- Age =/>40 or diabetes or known coronary disease or hypertension
- Requires hospital admission for further clinical management.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- COVID-19
- Being tested
- Aspirin 75mg, Clopidogrel 75mg, Rivaroxaban 2.5 MG, Atorvastatin 40mg, Omeprazole 20mg
- Keywords
- Coronavirus, SARS-CoV-2, COVID-19, Cardiovascular
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 75mgDrug
- If patient not on aspirin, add aspirin 75mg once daily unless contraindicated.
Clopidogrel 75mgDrug
- If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated
Rivaroxaban 2.5 MGDrug
- 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
Atorvastatin 40mgDrug
- If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated
Omeprazole 20mgDrug
- If patient not on a proton pump inhibitor, add omeprazole 20mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Not described Receives: Drug: Aspirin 75mg; Drug: Clopidogrel 75mg; Drug: Rivaroxaban 2.5 MG; Drug: Atorvastatin 40mg; Drug: Omeprazole 20mg |
| Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality
Measured: 30 days
Secondary outcomes (9)
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
Measured: 30 days
Peak troponin
Peak troponin within 7- and 30-days post randomization, if available.
Measured: 7- and 30- days
Time to discharge
Time to hospital discharge (length of stay)
Measured: Up to 30 days
Need for non-invasive ventilatory support
Need for non-invasive ventilatory support, if data available.
Measured: 30 days
Need for invasive ventilatory support
Need for invasive ventilatory support, if data available.
Measured: 30 days.
Need for mechanical circulatory support
Need for mechanical circulatory support, if data available.
Measured: 30 days
Need for renal replacement therapy
Need for renal replacement therapy, if data available.
Measured: 30 days
Bleeding Academic Research Consortium (BARC) bleed event
Bleeding Academic Research Consortium (BARC) bleed event, adjudicated
Measured: 30 days
Cessation of randomized active arm therapy
Cessation of randomized active arm therapy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start3 Apr 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Why it stopped: Difficulty in recruiting eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Multicentre Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prapa Kanagaratnam, FRCP, PhD, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333407
- Sponsor's protocol ID
- 20HH5868
- Acronym
- C-19-ACS
- Status last verified
- Jan 2023
- First submitted
- 1 Apr 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers or organisations. Anonymised data might be shared with other research organisations
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04333407
- Acronym / sponsor ID
- C-19-ACS / 20HH5868
- Conditions
- COVID-19
- Keywords
- Coronavirus, SARS-CoV-2, COVID-19, Cardiovascular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting eligible participants
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Multicentre Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Drug: Aspirin 75mg, Drug: Clopidogrel 75mg, Drug: Rivaroxaban 2.5 MG, Drug: Atorvastatin 40mg, Drug: Omeprazole 20mg |
| Control Arm | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed COVID-19 infection
- Age =/>40 or diabetes or known coronary disease or hypertension
- Requires hospital admission for further clinical management.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 75mg• If patient not on aspirin, add aspirin 75mg once daily unless contraindicated. | Drug | Active Arm |
| Clopidogrel 75mg• If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated | Drug | Active Arm |
| 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 | Active Arm |
| Atorvastatin 40mg• If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated | Drug | Active Arm |
| Omeprazole 20mg• If patient not on a proton pump inhibitor, add omeprazole 20mg once daily. | Drug | Active Arm |
Primary outcome
All-cause mortality
Time frame: 30 days
All-cause mortality
9 secondary outcomes
An ordinal outcome measure of 4 levels (1 - Death, 2 - Intensive Care Unit environment, 3 - In Hospital, 4 - At Home).
Time frame: 30 days
Peak troponin
Time frame: 7- and 30- days
Time to discharge
Time frame: Up to 30 days
Need for non-invasive ventilatory support
Time frame: 30 days
Need for invasive ventilatory support
Time frame: 30 days.
Need for mechanical circulatory support
Time frame: 30 days
Need for renal replacement therapy
Time frame: 30 days
Bleeding Academic Research Consortium (BARC) bleed event
Time frame: 30 days
Cessation of randomized active arm therapy
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Difficulty in recruiting eligible participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prapa Kanagaratnam, FRCP, PhD principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin 75mg, Clopidogrel 75mg and Rivaroxaban 2.5 MG in people with COVID-19, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting eligible participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.