COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-79
Anticoagulant Agent VS. Antiplatelet Agent VS. Placebo
A composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment.
Adults age between 40 and 80 years, COVID-19 positive, elevated D-dimer and hsCRP, who do not require hospitalization.
- Anticoagulation: prophylactic dose apixaban
- Anticoagulation: therapeutic dose apixaban
- Antiplatelet agent: low dose aspirin
7,000 in total (1,750 to each treatment arm) for Stage 1
Power and Interim Assessments
80% power to detect a 30% relative reduced risk
90% power to detect a 34% relative reduced risk
For stage 1, considering apixaban 5.0mg superiority with 8.0% placebo rate.
Minimum of weekly follow-up through Day 75.