Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
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: Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version), Usual care for atrial fibrillation.
- Кому может быть актуально
- Состояния в реестре: Acute Ischemic Stroke, Atrial Fibrillation. 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
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study will determine whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care.
Подробное описание
Atrial fibrillation is the single most frequent cause of ischemic stroke and associated with a high risk of recurrent stroke and cardiovascular complications. Usual care comprises oral anticoagulation and rate control. However, it is unclear, whether early rhythm control therapy reduces the risk of recurrent stroke and cardiovascular outcomes in stroke patients with atrial fibrillation. The Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE) will be an investigator-initiated, prospective, randomized, open, blinded outcome assessment (PROBE) interventional multi-center trial to test whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care. Primary outcome is a composite of recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or acute coronary syndrome. Secondary outcomes will involve a comprehensive array of clinical and safety parameters, health and socio-economic outcomes including patient reported outcome measures. In an adaptive design, up to 1,746 patients will be enrolled to demonstrate the expected treatment effect with 90% power.
Вмешательства
- Другое Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)
Therapy for early rhythm control will be either by use of approved antiarrhythmic drugs (e.g. amiodarone, dronedarone, flecainide, propafenone), approved approaches and devices for ablation, or electric cardio version. - Другое Usual care for atrial fibrillation
Usual care for atrial fibrillation according to current guidelines. Usual care will mainly comprise rate control by approved drugs. We expect, that usual care will also comprise therapy for rhythm control in a small group of patients.
Первичные конечные точки
- Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome. [Срок оценки: Through study completion, an average of 42 months]
Вторичные конечные точки (12)
- Time to first recurrent stroke [Срок оценки: Through study completion, an average of 42 months]
- Time to cardiovascular death [Срок оценки: Through study completion, an average of 42 months]
- Time to first hospitalization due to worsening of heart failure [Срок оценки: Through study completion, an average of 42 months]
- Time to hospitalization due to acute coronary syndrome [Срок оценки: Through study completion, an average of 42 months]
- Time to recurrent AF [Срок оценки: Through study completion, an average of 42 months]
- Cardiovascular hospitalization [Срок оценки: Through study completion, an average of 42 months]
- All-cause hospitalizations [Срок оценки: Through study completion, an average of 42 months]
- Time in sinus rhythm [Срок оценки: Through study completion, an average of 42 months]
- Functional status assessed by the modified Rankin Scale [Срок оценки: at 12 and 24 months]
- Quality of life assessed by the EuroQol five-dimensional questionnaire (EQ-5D) [Срок оценки: at 12 and 24 months]
- Cognitive function assessed by the Montreal Cognitive Assessment (MoCA) [Срок оценки: at 12 and 24 months]
- Cost of therapy [Срок оценки: Through study completion, an average of 42 months]
Критерии участия
Критерии включения
- Acute ischemic stroke in the previous four weeks, diagnosed by imaging (CT or MRI) or clinical diagnosis
- Possibility to start the trial treatment within 4 weeks after stroke, and as soon as clinically justifiable
- AF first detected ≤1 year prior to randomization
- Informed consent
Критерии исключения
- End-stage cancer or life-expectancy < 12 months due to other advanced co-morbid illness
- Prior AF ablation or surgical therapy of AF
- Patients not suitable for rhythm control of AF due to cardiac conditions
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
Германия · 1 центр
- University Medical Center Hamburg-Eppendorf — Hamburg
Публикации
- Jensen M, Zapf A, Buchholz A, Mohl A, Andrade JG, Cameron A, Campbell BCV, Fischer U, Hill MD, Kelly P, Kalman JM, Loh P, Molina C, Guasch E, Metzner A, Ng GA, Pagola J, Pontes-Neto OM, Reichlin T, Salman RA, Shoamanesh A, Sposato LA, van der Worp HB, Kirchhof P, Thomalla G. Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE): protocol for an internatio PMID 42153760
Идентификаторы
NCT: NCT05293080 · EAST-STROKE