6/28/23, 12:00 AM ACTIV-4C Pathway Feedback Search Clinical Topics Home Studies ACTIV 4C ACTIV 4C Disease COVID 19 infection 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 N = 1217 50.0% male 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 https://web.pathway.md/studies/rec3r61fG0qJL5fq2 1/2 6/28/23, 12:00 AM ACTIV-4C Pathway Composite of death, arterial thromboembolism, and venous thromboembolism at day 30 2.3 % 2.31 2.13 1.7 % 1.2 % 0.6 % No significant difference 0.0 % Apixaban Placebo 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. Open reference URL https://web.pathway.md/studies/rec3r61fG0qJL5fq2 2/2