ACTIV-4C
Trial question
What is the effect of thromboprophylaxis in patients discharged after COVID-19 hospitalization?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
50.0% female
50.0% male
N = 1217
1217 patients (614 female, 603 male)
Inclusion criteria: adult patients hospitalized with COVID-19 for ≥ 48 hours and ready for discharge
Key exclusion criteria: existing indication for either therapeutic or prophylactic dose anticoagulation at hospital discharge; contraindication to antithrombotic therapy; inherited or active acquired bleeding disorder
Interventions
N=610 apixaban (a dose of 2.5 mg BID for 30 days)
N=607 placebo (matching placebo BID for 30 days)
Primary outcome
Composite of death, arterial thromboembolism, and venous thromboembolism at day 30
2.13
2.31
2.3 %
1.7 %
1.2 %
0.6 %
0.0 %
Apixaban
Placebo
No significant difference ↔
No significant difference in composite of death, arterial thromboembolism, and VTE at day 30 (2.13% vs. 2.31%; RR 0.92, 95% CI 0.44 to 1.95)
Secondary outcomes
No significant difference in arterial thromboembolism (0.16% vs. 0.49%; RR 0.33, 95% CI 0.03 to 3.18)
No significant difference in death from all causes (1.31% vs. 1.48%; RR 0.88, 95% CI 0.34 to 2.28)
No significant difference in composite of death, arterial thromboembolism, and VTE at day 90 (3.11% vs. 2.8%; RR 1.11, 95% CI 0.58 to 2.12)
Safety outcomes
No significant differences in serious adverse events, major bleeding and clinically relevant nonmajor bleeding.
Conclusion
In adult patients hospitalized with COVID-19 for ≥ 48 hours and ready for discharge, apixaban was not superior to placebo with respect to the composite of death, arterial thromboembolism, and VTE at day 30.
Reference
Tracy Y Wang, Abdus S Wahed, Alison Morris et al. Effect of Thromboprophylaxis on Clinical Outcomes After COVID-19 Hospitalization. Ann Intern Med. 2023 Mar 21;M22-3350.
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