6/30/23, 2:20 AM TRAPS Pathway Feedback Search Clinical Topics Home Studies TRAPS TRAPS Disease Antiphospholipid syndrome Trial question Is rivaroxaban noninferior to warfarin in high-risk patients with thrombotic antiphospholipid syndrome? Study design Multi-center Open label RCT Population Characteristics of study participants 64.0% female N = 120 36.0% male 120 patients (77 female, 43 male) Inclusion criteria: high-risk patients with thrombotic antiphospholipid syndrome Key exclusion criteria: severe hypersensitivity to rivaroxaban, pregnancy or breast feeding, concomitant treatment with other anticoagulants, major surgical procedure or trauma within 30 days, gastrointestinal bleeding within 6 months of randomization, chronic hemorrhagic disorder, intracranial neoplasm, AVM or aneurysm Interventions N=59 rivaroxaban (20 mg once daily; 15 mg once daily based on kidney function) N=61 warfarin (INR target 2.5) https://web.pathway.md/studies/recmv6xb2KgXegXby 1/2 6/30/23, 2:20 AM TRAPS Pathway Primary outcome Vascular death, thromboembolic events, or major bleeding 19.0 % 19 14.3 % 9.5 % Difference exceeding nonferiority margin 4.8 % 3 0.0 % Rivaroxaban Warfarin Difference exceeding nonferiority margin in vascular death, thromboembolic events, or major bleeding (19% vs. 3%; HR 6.7, 95% CI 1.5 to 30.5) Secondary outcomes No significant difference in major bleeding (7% vs. 3%; HR 2.5, 95% CI 0.5 to 13.6) Conclusion In high-risk patients with thrombotic antiphospholipid syndrome, rivaroxaban was not noninferior to warfarin with respect to vascular death, thromboembolic events, or major bleeding. Reference Pengo V, Denas G, Zoppellaro G et al. Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. Blood. 2018 Sep 27;132(13):1365-1371. Open reference URL https://web.pathway.md/studies/recmv6xb2KgXegXby 2/2