Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease

Официальное название

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)

Обзор

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

Вмешательства

• Препарат REGN7508
  Administered per the protocol
• Препарат REGN9933
  Administered per the protocol
• Препарат Placebo
  Administered per the protocol
• Препарат Rivaroxaban
  Administered per the protocol

Первичные конечные точки

• 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 [Срок оценки: Approximately up to 42 months]
• Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleeding [Срок оценки: Approximately up to 42 months]

Вторичные конечные точки (12)

• 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 [Срок оценки: Approximately up to 42 months]
• 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) [Срок оценки: Approximately up to 42 months]
• Time-to-first occurrence of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke or coronary death [Срок оценки: Approximately up to 42 months]
• Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature [Срок оценки: Approximately up to 42 months]
• Time-to-first occurrence of ALI, major amputation of vascular etiology, MI, ischemic stroke, or all-cause mortality [Срок оценки: Approximately up to 42 months]
• Time-to-first occurrence of unplanned index limb revascularization for ischemia [Срок оценки: Approximately up to 42 months]
• Time-to-first occurrence of VTE [Срок оценки: Approximately up to 42 months]
• Time-to-all-cause mortality [Срок оценки: Approximately up to 42 months]
• Time-to-first occurrence of Major Adverse Limb Event (MALE) [Срок оценки: Approximately up to 42 months]
• Time-to-first occurrence of Major Adverse Cardiovascular Event (MACE) [Срок оценки: Approximately up to 42 months]
• Time-to-first occurrence of a major thrombotic vascular event or ISTH fatal/critical organ bleeding (net clinical benefit) [Срок оценки: Approximately up to 42 months]
• Time-to-first occurrence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding [Срок оценки: Approximately up to 42 months]

Критерии участия

Критерии включения

• 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
• At least 1 of the following enrichment factors for major thrombotic vascular events:

• Bypass with prosthetic graft
• Endovascular treatment with stenting
• Target lesion length >15 cm
• History of LER or amputation for PAD prior to qualifying LER
• Type 2 diabetes mellitus requiring pharmacologic treatment
• Comorbid symptomatic coronary artery disease as described in the protocol
• Chronic kidney disease as described in the protocol
• Age ≥75 years

Критерии исключения

• 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/1.73m\^2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization
• Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study period
• Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 13 центров

• Lake Martin Medical and Vascular Center — Alexander City
• Axsendo Clinical Research, Integrated Medical Services — Avondale
• Applied Research Center of Arkansas — Little Rock
• Nature Coast Clinical Research - Cardiology — Crystal River
• Profound Research, Powers Health Medical Group — Munster
• Cardiovascular Solutions — Shreveport
• Accellacare of Piedmont, Piedmont Healthcare — Mooresville
• Apex Research Foundation, LLC — Jackson
• … и ещё 5 центров

Идентификаторы

NCT: NCT07318610 · R9933-PAD-2394 · 2025-522954-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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