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

NCT04333407 | Terminated DMC

• 1 other identifier: 20HH5868
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Coronavirus, SARS-CoV-2, COVID-19, Cardiovascular

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  All-cause mortality

  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).

  30 days

• Peak troponin

  7- and 30- days

• Time to discharge

  Up to 30 days

• Need for non-invasive ventilatory support

  30 days

• Need for invasive ventilatory support

  30 days.

Study Arms (2)

Active Arm

EXPERIMENTAL

Drug: Aspirin 75mg; Drug: Clopidogrel 75mg; Drug: Rivaroxaban 2.5 MG; Drug: Atorvastatin 40mg; Drug: Omeprazole 20mg

Control Arm

NO INTERVENTION

Interventions

Aspirin 75mg DRUG

• If patient not on aspirin, add aspirin 75mg once daily unless contraindicated.

Active Arm

Clopidogrel 75mg DRUG

• If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated

Active Arm

Rivaroxaban 2.5 MG DRUG

* 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

Active Arm

Atorvastatin 40mg DRUG

• If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated

Active Arm

Omeprazole 20mg DRUG

• If patient not on a proton pump inhibitor, add omeprazole 20mg once daily.

Active Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Aspirin; Clopidogrel; Rivaroxaban; Atorvastatin; Omeprazole

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Morpholines; Oxazines; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Benzimidazoles

Study Officials

• Prapa Kanagaratnam, FRCP, PhD

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Multicentre Randomised Controlled Trial

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: April 3, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)