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Набор скоро начнётся NCT07626411

Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

Фаза III С лечением Atrial Fibrillation (AF)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: REGN7508, Apixaban, Placebo.
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation (AF). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508, a Monoclonal Antibody Against Factor XI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-EVEREST)

Обзор

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Вмешательства

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

Первичные конечные точки

  • Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism [Срок оценки: Approximately 36 months]
  • Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding or ISTH Clinically Relevant Non-Major (CRNM) bleeding [Срок оценки: Approximately 36 months]
Вторичные конечные точки (12)
  • Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or ISTH CRNM bleeding [Срок оценки: Approximately 36 months]
  • Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, or ISTH major bleeding [Срок оценки: Approximately 36 months]
  • Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or all-cause death [Срок оценки: Approximately 36 months]
  • Time to first occurrence of ISTH major bleeding [Срок оценки: Approximately 36 months]
  • Time to first occurrence of hemorrhagic stroke, intracerebral hemorrhage, or hemorrhagic transformation of an ischemic stroke [Срок оценки: Approximately 36 months]
  • Time to occurrence of fatal bleeding [Срок оценки: Approximately 36 months]
  • Number of ISTH major bleeding events [Срок оценки: Approximately 36 months]
  • Number of ISTH CRNM bleeding events [Срок оценки: Approximately 36 months]
  • Number of minor bleeding events [Срок оценки: Approximately 36 months]
  • Time to all-cause death [Срок оценки: Approximately 36 months]
  • Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Approximately 39 months]
  • Severity of TEAEs [Срок оценки: Approximately 39 months]

Критерии участия

Критерии включения

  • Has AF or flutter (paroxysmal or persistent), not considered 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 \[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years\] 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 Normalized 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 a successful ablation therapy without documented recurrent AF or a participant after Left Atrial Appendage (LAA) occlusion/exclusion or plan for ablation or LAA occlusion/exclusion within the next 6 months starting from randomization
  • Had an ischemic stroke within 2 days prior to randomization
  • Has persistent, uncontrolled hypertension (per investigator's discretion)
  • Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m2 within 30 days prior to randomization or is on dialysis or expected to be started on dialysis within the next 6 months starting from 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
Четверное слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07626411 · R7508-CVA-24114 · 2025-521617-97-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗