NCT04333407

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2020-04-03
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2020-04-03
• Last updated: 2023-01-18

Locations

1 site across 1 country: United Kingdom