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An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients With Symptomatic Peripheral Artery Disease Undergoing Lower Extremity Revascularization Procedures

Primary efficacy objective: to evaluate whether rivaroxaban added to acetylsalicylic acid (ASA) is superior to ASA alone in reducing the risk of major thrombotic vascular events (defined as myocardial infarction (MI), ischemic stroke, cardiovascular (CV) death, acute limb ischemia (ALI), and major amputation of a vascular etiology) in symptomatic PAD patients undergoing lower extremity revascularization procedure. Secondary efficacy objectives: to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, ischemic stroke, coronary heart disease mortality, ALI, and major amputation of a vascular etiology; to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of an unplanned index limb revascularization for recurrent limb ischemia (subsequent index leg revascularizations that were not planned or considered as part of the initial treatment plan at the time of randomization);3 to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of vascular hospitalizations for a coronary or peripheral event (either limb) of a thrombotic nature; to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, ischemic stroke, all-cause mortality, ALI, and major amputation of a vascular etiology; to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, all-cause stroke, CV death, ALI, and major amputation of a vascular etiology; to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of all-cause mortality to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of venous thromboembolic (VTE) events4; Primary safety objective: to evaluate the overall safety and tolerability of rivaroxaban added to ASA compared to ASA alone.

Primary efficacy objective: to evaluate whether rivaroxaban added to acetylsalicylic acid (ASA) is superior to ASA alone in reducing the risk of major thrombotic vascular events (defined as myocardial infarction (MI), ischemic stroke, cardiovascular (CV) death, acute limb ischemia (ALI), and major amputation of a vascular etiology) in symptomatic PAD patients undergoing lower extremity revascularization procedure. Secondary efficacy objectives: to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, ischemic stroke, coronary heart disease mortality, ALI, and major amputation of a vascular etiology; to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of an unplanned index limb revascularization for recurrent limb ischemia (subsequent index leg revascularizations that were not planned or considered as part of the initial treatment plan at the time of randomization);3 to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of vascular hospitalizations for a coronary or peripheral event (either limb) of a thrombotic nature; to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, ischemic stroke, all-cause mortality, ALI, and major amputation of a vascular etiology; to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, all-cause stroke, CV death, ALI, and major amputation of a vascular etiology; to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of all-cause mortality to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of venous thromboembolic (VTE) events4; Primary safety objective: to evaluate the overall safety and tolerability of rivaroxaban added to ASA compared to ASA alone.