Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

Официальное название

A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against FXI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-ATLAS)

Обзор

This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots. The study is looking at several other research questions, including: * What side effects may happen from taking REGN7508 or REGN9933 * How well do the study drugs reduce the risk of having a stroke * How much of REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)

Вмешательства

• Препарат REGN7508
  Administered per the protocol
• Препарат REGN9933
  Administered per the protocol
• Препарат Apixaban
  Administered per the protocol

Первичные конечные точки

• Incidence of any bleeding [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

• Incidence of the composite of ISTH major bleeding or ISTH CRNM bleeding [Срок оценки: 12 weeks]
• Incidence of ISTH major bleeding [Срок оценки: 12 weeks]
• Incidence of ISTH CRNM bleeding [Срок оценки: 12 weeks]
• Incidence of minor bleeding [Срок оценки: 12 weeks]
• Number of ISTH major bleeding events [Срок оценки: 12 weeks]
• Number of ISTH CRNM bleeding events [Срок оценки: 12 weeks]
• Number of minor bleeding events [Срок оценки: 12 weeks]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Approximately 25 weeks]
• Severity of TEAEs [Срок оценки: Approximately 25 weeks]
• Incidence of the composite of stroke or systemic embolism [Срок оценки: Approximately 12 weeks]
• Incidence of Antidrug Antibodies (ADA) to REGN7508 [Срок оценки: 12 weeks]
• Magnitude of ADA to REGN7508 [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol
• Meets one of the following:

• CHA2DS2-VA \[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years\] score ≥2 and Oral Anticoagulant (OAC) naïve or
• CHA2DS2-VA score ≥3 or
• CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol
• Must have an International Normalization Ratio (INR) <2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)

Критерии исключения

• Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
• Has known moderate-to-severe mitral stenosis
• Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol
• Had an ischemic stroke within 2 days prior to randomization
• Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m\^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol
• Has a history of central nervous system bleeding within 30 days prior to randomization

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

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 42 центра

• SEC Clinical Research — Dothan
• Eastern Shore Research Institute — Fairhope
• Valley Clinical Trials, Inc — Covina
• North Coast Cardiology — Encinitas
• Mission Cardiovascular Research Institute — Fremont
• National Institute of California Heart and Vein Specialists — Huntington Beach
• Profound Research LLC at Southern California Heart Specialists — Pasadena
• Empire Clinical Research — Pomona
• … и ещё 34 центра

Бразилия · 15 центров

• Hospital Ruy Azeredo — Goiânia
• Cardiologia Assistencial e de Pesquisa Ltda (Cardresearch) — Belo Horizonte
• Nucleo de Pesquisa do Hospital Cardiologico Costantini (NUPEC) — Belo Horizonte
• Hospital Maternidade e Pronto Socorro Santa Lucia — Poços de Caldas
• Sociedade Hospitalar Angelina Caron — Campina Grande do Sul
• Pontificia Universidade Catolica do Paraná (PUC) Trials — Curitiba
• Nucleo de Pesquisa Clínica SS — Curitiba
• Hospital Ernesto Dornelles — Porto Alegre
• … и ещё 7 центров

Канада · 13 центров

• University of Alberta Hospital - Cardiology — Edmonton
• Victoria Cardiac Arrhythmia Trials — Victoria
• GA Research Associates Ltd. — Moncton
• Health sciences North - Cardiology — Greater Sudbury
• Hamilton Health Sciences Corporation — Hamilton
• Hamilton Medical Research Group (HMRG) — Hamilton
• Dr James Cha — Oshawa
• Heart Health Institute Research Inc. - Cardiology — Scarborough Village
• … и ещё 5 центров

Аргентина · 4 центра

• Centro de Investigacion Clinica — Ciudad Autonoma de Buenos Aires
• Fundacion Estudios Clinicos - Cardiologia — Rosario
• STAT Research Argentina — Buenos Aires
• Centro de Investigaciones Clinicas del Litoral - Cardiologia — Santa Fe

Идентификаторы

NCT: NCT07175428 · R7508-CVA-2393

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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