NCT04333407.

Study name	Preventing cardiac complication of COVID‐19 disease with early acute coronary syndrome therapy: a randomised controlled trial
Starting date	3 April 2020
Contact information	Alena Marynina Charing Cross Hospital, London, UK 07776 224520 | alena.marynina@nhs.net
Methods	Multicentre RCT with 2 parallels arms, 1:1, open label
Participants	3170 participants, ≥ 18 years, female and male Inclusion criteria Confirmed COVID‐19 infection Age ≥ 40 years, or diabetes, or known coronary disease, or hypertension Requires hospital admission for further clinical management Exclusion criteria Clear evidence of cardiac pathology needing ACS treatment Myocarditis with serum troponin > 5000 Bleeding risk suspected e.g. recent surgery, history of GI bleed, other abnormal blood results (Hb < 10 g/dL, platelets < 100, any evidence of DIC) Study treatment may negatively impact standard best care (physician discretion) Unrelated co‐morbidity with life expectancy < 3 months Pregnancy Age: < 18 years or > 85 years
Interventions	Experimental: active arm Drug: aspirin 75 mg. If participant not on aspirin, add aspirin 75 mg once daily unless contraindicated Drug: clopidogrel 75 mg. If participant not on clopidogrel or equivalent, add clopidogrel 75 mg once daily unless contraindicated Drug: rivaroxaban 2.5 mg. If participant not on an anticoagulation, add rivaroxaban 2.5 mg twice a day unless contraindicated. If participant on DOAC then change to rivaroxaban 2.5 mg unless contraindicated Drug: atorvastatin 40 mg. If participant not on a statin, add atorvastatin 40 mg once daily unless contraindicated Drug: omeprazole 20 mg. If participant not on a proton pump inhibitor, add omeprazole 20 mg once daily Comparator: no intervention
Outcomes	Primary All‐cause mortality at 30 days after admission (time frame: at 30 days after admission) Secondary Absolute change in serum troponin from admission to peak value (time frame: within 7 days and within 30 days of admission). Absolute change in serum troponin from admission (or from suspicion/diagnosis of COVID‐19 if already an inpatient) measurement to peak value (measured using high‐sensitivity troponin assay). (Phase I interim analysis) Discharge rate (time frame: at 7 days and 30 days after admission). Discharge rate: proportion of participants discharged (or documented as medically fit for discharge) Intubation rate (time frame: at 7 days and at 30 days after admission). Intubation rate: proportion of participants who have been intubated for mechanical ventilation
Notes	NCT04333407 | No data provided