A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants with Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)

Peripheral Artery Disease

[Cohort 1] Time-to-first occurrence of a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) death, [Cohort 1 and 2] Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleeding

[Cohort 1 and 2] Total (first and subsequent) occurrences of major thrombotic vascular events, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, or CV death, [Cohort 1 and 2] Time-to-first occurrence of an expanded thrombotic vascular event, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, CV death, unplanned index limb revascularization, or Venous Thromboembolism (VTE), [Cohort 1] Time-to-first occurrence of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke or coronary death, [Cohort 1]Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature, [Cohort 1]Time-to-first occurrence of ALI, major amputation of vascular etiology, MI, ischemic stroke, or all-cause mortality, [Cohort 1]Time-to-first occurrence of unplanned index limb revascularization for ischemia, [Cohort 1] Time-to-first occurrence of VTE, [Cohort 1] Time-to-all-cause mortality, [Cohort 1]Time-to-first occurrence of Major Adverse Limb Event (MALE), [Cohort 1]Time-to-first occurrence of Major Adverse Cardiovascular Event (MACE), [Cohort 1] Time-to-first occurrence of a major thrombotic vascular event or ISTH fatal/critical organ bleeding (net clinical benefit), [Cohort 1 and 2] Time-to-first occurrence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, [Cohort 1 and 2] Occurrence of Treatment-Emergent Adverse Event (TEAEs), [Cohort 1 and 2] Severity of TEAEs, [Cohort 1 and 2] Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time, [Cohort 1 and 2] Magnitude of ADA to REGN7508 over time, [Cohort 1 and 2] Occurrence of ADA to REGN9933 over time, [Cohort 1 and 2] Magnitude of ADA to REGN9933 over time, [Cohort 1 and 2] Concentrations of REGN7508 over time, [Cohort 1 and 2] Concentrations of REGN9933 over time, [Cohort 1 and 2] Change from baseline in activated Partial Thromboplastin Time (aPTT) over time, [Cohort 1 and 2] Change from baseline in Prothrombin Time (PT)/International Normalization Ratio (INR) over time, [Cohort 2]Total (first and subsequent) occurrences of expanded thrombotic vascular events, [Cohort 2] Time-to-first occurrence of a major thrombotic vascular event, [Cohort 2] Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, or CV death, [Cohort 2] Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, CV death, unplanned index limb revascularization, or VTE

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