This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become too narrow. People with PAD have a higher risk of getting blood clots after procedures like Lower Extremity Revascularization (LER), a procedure to improve blood flow in the legs and feet.
The aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently had LER. The effects of REGN7508 and REGN9933, individually, will also be compared to rivaroxaban and a placebo.
The study is looking at several other research questions, including:
* What side effects might happen from taking the study drugs and how do they compare to the side effects of rivaroxaban * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * If the study drugs affect the ability of the blood to clot normally
Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in the protocol
Bypass with prosthetic graft
Endovascular treatment with stenting
Target lesion length >15 cm
Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome
Has known bleeding diathesis, platelet count <50,000/mm^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy, or known unrepaired cerebrovascular malformations
Has recent coronary revascularization as described in the protocol
For Cohort 2 only: Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m² within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization
Parallel
REGN7508
DrugAdministered per the protocol
REGN9933
DrugAdministered per the protocol
Placebo
DrugAdministered per the protocol
Rivaroxaban
DrugAdministered per the protocol
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
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 and 2
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
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