6/28/23, 12:38 AM AMPLIFY Pathway Feedback Search Clinical Topics Home Studies AMPLIFY AMPLIFY Disease Disease Deep vein thrombosis Pulmonary embolism Trial question What is the role of apixaban in patients with acute VTE? Study design Multi-center Double blinded RCT Population Characteristics of study participants 41.0% female N = 5395 59.0% male 5395 patients (2228 female, 3167 male) Inclusion criteria: patients with acute VTE Key exclusion criteria: active bleeding, a high risk of bleeding, or other contraindications to treatment with enoxaparin and warfarin, cancer and long-term treatment with low-molecular- weight heparin was planned, or dual antiplatelet therapy Interventions N=2609 apixaban (10 mg PO BID for 7 days, followed by 5 mg PO BID for 6 months) N=2635 warfarin (subcutaneous enoxaparin, followed by warfarin) Primary outcome Recurrent symptomatic venous thromboembolism or death related to venous thromboembolism https://web.pathway.md/studies/recchDH8YMZNaqn0Y 1/2 6/28/23, 12:38 AM AMPLIFY Pathway 2.7 % 2.7 2.3 2.0 % 1.4 % Difference not exceeding nonferiority margin 0.7 % 0.0 % Apixaban Warfarin Difference not exceeding nonferiority margin in recurrent symptomatic VTE or death related to VTE (2.3% vs. 2.7%; RR 0.84, 95% CI 0.6 to 1.18) Secondary outcomes No significant difference in VTE or death from cardiovascular cause (2.3% vs. 2.9%; RR 0.8, 95% CI 0.57 to 1.11) No significant difference in VTE or death from any cause (3.2% vs. 3.9%; RR 0.82, 95% CI 0.61 to 1.08) Significant decrease in VTE, death related to VTE, or major bleeding (2.8% vs. 4.5%; RR 0.62, 95% CI 0.47 to 0.83) Safety outcomes No significant difference in any adverse event. Significant difference in major bleeding (0.6% vs. 1.8%) and major bleeding plus clinically relevant nonmajor bleeding (4.3% vs. 9.7%). Conclusion In patients with acute VTE, apixaban was noninferior to warfarin with respect to recurrent symptomatic VTE or death related to VTE. Reference Agnelli G, Buller HR, Cohen A et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. Open reference URL https://web.pathway.md/studies/recchDH8YMZNaqn0Y 2/2