6/28/23, 12:00 AM ACTIV-4A Pathway Feedback Search Clinical Topics Home Studies ACTIV 4A ACTIV 4A Disease COVID 19 infection Trial question What is the effect of P2Y12 inhibitor plus heparin in non-critically ill patients hospitalized for COVID- 19? Study design Multi-center Open label RCT Population Characteristics of study participants 41.0% female N = 562 59.0% male 562 patients (233 female, 329 male) Inclusion criteria: non-critically ill patients hospitalized for COVID-19 Key exclusion criteria: severe illness requiring admission to ICU; imminent death; pregnancy; contraindication to anticoagulation; Hgb < 8 g/dL; platelet count < 50x 10 /L Interventions N=293 P2Y12 inhibitor plus heparin (ticagrelor, clopidogrel, or prasugrel plus therapeutic dose heparin for 14 days or until hospital discharge) N=269 usual care (therapeutic dose of heparin only) Primary outcome https://web.pathway.md/studies/rec1MnMueDp1oxhhW 1/2 6/28/23, 12:00 AM ACTIV-4A Pathway Organ support-free days 21.0 days 21 21 15.8 days 10.5 days 5.3 days No significant difference 0.0 days P2Y12 inhibitor plus heparin Usual care No significant difference in organ support-free days (21 days vs. 21 days; aOR 0.83, 95% CI 0.55 to 1.25) Secondary outcomes No significant difference in major thrombotic events or death in the hospital (6.1% vs. 4.5%; aOR 1.42, 95% CI 0.64 to 3.13) No significant difference in thrombotic events or death in the hospital (6.8% vs. 4.5%; aOR 1.6, 95% CI 0.73 to 3.5) No significant difference in major bleeding events or death in the hospital (6.1% vs. 3.7%; aOR 1.8, 95% CI 0.79 to 4.1) Safety outcomes No significant difference in major bleeding events. Conclusion In non-critically ill patients hospitalized for COVID-19, P2Y12 inhibitor plus heparin was not superior to usual care with respect to organ support-free days. Reference Jeffrey S Berger, Lucy Z Kornblith, Michelle N Gong et al. Effect of P2Y12 Inhibitors on Survival Free of Organ Support Among Non-Critically Ill Hospitalized Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2022 Jan 18;327(3):227-236. Open reference URL https://web.pathway.md/studies/rec1MnMueDp1oxhhW 2/2