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

COVID-19 Clinical Trial

— C-19-ACS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04333407
• Other study ID #: 20HH5868
• Status: Terminated
• Phase: N/A
• Start date: April 3, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: January 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 320
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• COVID-19

Intervention

Drug:
• Aspirin 75mg
• If patient not on aspirin, add aspirin 75mg once daily unless contraindicated.
• Clopidogrel 75mg
• If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated
• 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
• Atorvastatin 40mg
• If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated
• Omeprazole 20mg
• If patient not on a proton pump inhibitor, add omeprazole 20mg once daily.

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All-cause mortality	30 days
Secondary	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	30 days
Secondary	Peak troponin	Peak troponin within 7- and 30-days post randomization, if available.	7- and 30- days
Secondary	Time to discharge	Time to hospital discharge (length of stay)	Up to 30 days
Secondary	Need for non-invasive ventilatory support	Need for non-invasive ventilatory support, if data available.	30 days
Secondary	Need for invasive ventilatory support	Need for invasive ventilatory support, if data available.	30 days.
Secondary	Need for mechanical circulatory support	Need for mechanical circulatory support, if data available.	30 days
Secondary	Need for renal replacement therapy	Need for renal replacement therapy, if data available.	30 days
Secondary	Bleeding Academic Research Consortium (BARC) bleed event	Bleeding Academic Research Consortium (BARC) bleed event, adjudicated	30 days
Secondary	Cessation of randomized active arm therapy	Cessation of randomized active arm therapy	30 days