6/28/23, 11:16 PM MAGELLAN Pathway Feedback Search Clinical Topics Home Studies MAGELLAN MAGELLAN Disease Disease Deep vein thrombosis Pulmonary embolism Trial question Is rivaroxaban noninferior to enoxaparin for thromboprophylaxis in acutely ill medical patients? Study design Multi-center Double blinded RCT Population Characteristics of study participants 46.0% female N = 8101 54.0% male 8101 patients (3712 female, 4389 male) Inclusion criteria: patients 40 years of age who were hospitalized for an acute medical illness Key exclusion criteria: contraindication for LMWH enoxaparin, risk of bleeding, known allergy to rivaroxaban, severe renal insufficiency, known HIV infection at screening, or history of ongoing drug or alcohol abuse Interventions N=4050 rivaroxaban (subcutaneous placebo for 10 +/- 4 days and oral rivaroxaban, 10 mg once daily, for 35 +/- 4 days) N=4051 enoxaparin (subcutaneous enoxaparin, 40 mg once daily, for 10 +/- 4 days and oral placebo for 35 +/- 4 days) https://web.pathway.md/studies/recZH9vG65mV4VYkt 1/2 6/28/23, 11:16 PM MAGELLAN Pathway Primary outcome Asymptomatic proximal or symptomatic venous thromboembolism at day 10 2.7 % 2.7 2.7 2.0 % 1.4 % Difference not exceeding nonferiority margin 0.7 % 0.0 % Rivaroxaban Enoxaparin Difference not exceeding nonferiority margin in asymptomatic proximal or symptomatic VTE at day 10 (2.7% vs. 2.7%; RR 0.97, 95% CI 0.71 to 1.31) Secondary outcomes Significant decrease in asymptomatic proximal or symptomatic VTE at 35 days (4.4% vs. 5.7%; RR 0.77, 95% CI 0.62 to 0.96) Safety outcomes Significant differences in composite of major or clinically relevant nonmajor bleeding at day 10 (2.8% vs. 1.2%, p < 0.001) and at day 35 (4.1% vs. 1.7%, p < 0.001). Conclusion In patients 40 years of age who were hospitalized for an acute medical illness, rivaroxaban was noninferior to enoxaparin with respect to asymptomatic proximal or symptomatic VTE at day 10. Reference Cohen AT, Spiro TE, Buller HR et al. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. Open reference URL https://web.pathway.md/studies/recZH9vG65mV4VYkt 2/2