6/28/23, 12:04 AM CASSINI Pathway Feedback Search Clinical Topics Home Studies CASSINI CASSINI Disease Cancer-associated thrombosis Trial question What is the role of rivaroxaban in high-risk ambulatory patients with cancer? Study design Multi-center Double blinded RCT Population Characteristics of study participants 49.0% female N = 841 51.0% male 841 patients (413 female, 428 male) Inclusion criteria: high-risk ambulatory adults with cancer Key exclusion criteria: primary brain tumor or known brain metastases; active bleeding or at risk for bleeding; ECOG performance-status score of 3 Interventions N=420 rivaroxaban (a dose of 10 mg daily for 6 months) N=421 placebo (matching placebo daily for 6 months) Primary outcome Thrombotic events at 6 months 8.8 % 8.8 6.6 % 6 4 4 % https://web.pathway.md/studies/rec5v70paFtB83aAQ 1/2 6/28/23, 12:04 AM CASSINI Pathway 4.4 % 2.2 % No significant difference 0.0 % Rivaroxaban Placebo No significant difference in thrombotic events at 6 months (6% vs. 8.8%; HR 0.66, 95% CI 0.4 to 1.09) Secondary outcomes No significant difference in death at day 180 (20% vs. 23.8%; HR 0.83, 95% CI 0.62 to 1.11) No significant difference in symptomatic proximal deep vein thrombosis in the lower limb at day 180 (2.1% vs. 1.9%; HR 1.12, 95% CI 0.43 to 2.91) No significant difference in symptomatic distal deep vein thrombosis in the lower limb at day 180 (0.5% vs. 1.2%; HR 0.4, 95% CI 0.08 to 2.07) Safety outcomes No significant differences in major bleeding, clinically relevant nonmajor bleeding, adverse and serious adverse events. Conclusion In high-risk ambulatory adults with cancer, rivaroxaban was not superior to placebo with respect to thrombotic events at 6 months. Reference Alok A Khorana, Gerald A Soff, Ajay K Kakkar et al. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. Open reference URL https://web.pathway.md/studies/rec5v70paFtB83aAQ 2/2