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

NCT ID: NCT04333407

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-03
• Study Completion Date: 2021-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Arm

Group Type: EXPERIMENTAL

Aspirin 75mg

Intervention Type: DRUG

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

Clopidogrel 75mg

Intervention Type: DRUG

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

Rivaroxaban 2.5 MG

Intervention Type: 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

Atorvastatin 40mg

Intervention Type: DRUG

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

Omeprazole 20mg

Intervention Type: DRUG

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

Control Arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aspirin 75mg

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

Intervention Type: DRUG

Clopidogrel 75mg

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

Intervention Type: 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

Intervention Type: DRUG

Atorvastatin 40mg

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

Intervention Type: DRUG

Omeprazole 20mg

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prapa Kanagaratnam, FRCP, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College Healthcare NHS Trust

Locations

Charing Cross Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

20HH5868

Identifier Type: -

Identifier Source: org_study_id