Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.
- Conditions
- COVID-19
- Interventions
- Registration Number
- NCT04333407
- Lead Sponsor
- Imperial College London
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 320
- Confirmed COVID-19 infection
- Age =/>40 or diabetes or known coronary disease or hypertension
- Requires hospital admission for further clinical management.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Arm Rivaroxaban 2.5 MG - Active Arm Atorvastatin 40mg - Active Arm Aspirin 75mg - Active Arm Clopidogrel 75mg - Active Arm Omeprazole 20mg -
- Primary Outcome Measures
Name Time Method All-cause mortality 30 days All-cause mortality
- Secondary Outcome Measures
Name Time Method An ordinal outcome measure of 4 levels (1 - Death, 2 - Intensive Care Unit environment, 3 - In Hospital, 4 - At Home). 30 days - In Hospital, 4 - At Home), using a Bayesian longitudinal ordinal model over 30 days
Peak troponin 7- and 30- days Peak troponin within 7- and 30-days post randomization, if available.
Time to discharge Up to 30 days Time to hospital discharge (length of stay)
Need for non-invasive ventilatory support 30 days Need for non-invasive ventilatory support, if data available.
Need for invasive ventilatory support 30 days. Need for invasive ventilatory support, if data available.
Need for mechanical circulatory support 30 days Need for mechanical circulatory support, if data available.
Need for renal replacement therapy 30 days Need for renal replacement therapy, if data available.
Bleeding Academic Research Consortium (BARC) bleed event 30 days Bleeding Academic Research Consortium (BARC) bleed event, adjudicated
Cessation of randomized active arm therapy 30 days Cessation of randomized active arm therapy
Trial Locations
- Locations (1)
Charing Cross Hospital
🇬🇧London, United Kingdom