Идёт набор NCT03968393

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress

Фаза IV С лечением Stroke Atrial Fibrillation

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: Non-vitamin K oral anticoagulant (NOAC).
Кому может быть актуально: Состояния в реестре: Stroke, Atrial Fibrillation. Базовые параметры: от 55 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: США, Аргентина, Австралия, Бразилия, Канада +13
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

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress - The ASPIRE-AF Trial

Обзор

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.

Подробное описание

ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient atrial fibrillation and additional stroke factors occurring transiently with stress. The primary objective is to assess the effects of NOACs versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.

Вмешательства

Препарат Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.

Первичные конечные точки

Incidence of Non-hemorrhagic stroke or systemic embolism [Срок оценки: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism [Срок оценки: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]

Вторичные конечные точки (8)

Incidence of vascular mortality [Срок оценки: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of non-fatal, non-hemorrhagic stroke [Срок оценки: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of Myocardial infarction [Срок оценки: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of peripheral arterial thrombosis [Срок оценки: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of amputation [Срок оценки: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of symptomatic venous thromboembolism [Срок оценки: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of all-cause stroke [Срок оценки: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of all-cause mortality [Срок оценки: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]

Критерии участия

Критерии включения

have ≥1 episode of clinically important AFOTS during any of the following conditions:

noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator;
sinus rhythm at the time of randomization;
any of the following high-risk criteria:

age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR
age ≥75 years.;
provide written informed consent

Критерии исключения

any cardiac diagnosis as the primary reason for hospital admission;
history of documented chronic AF prior to noncardiac surgery;
need for long-term systemic anticoagulation;
ongoing need for long-term dual antiplatelet treatment;
contraindication to oral anticoagulation;
severe renal insufficiency (CrCl <20 ml/min);
severe liver cirrhosis (i.e., Child-Pugh Class C)
acute stroke in the past 14 days;
underwent cardiac surgery in the past 35 days;
history of nontraumatic intracranial, intraocular, or spinal bleeding;
hemorrhagic disorder or bleeding diathesis;
expected to be non-compliant with follow-up and/or study medications;
known life expectancy less than 1 year due to concomitant disease;
women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
previously enrolled in the trial

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

Канада · 24 центра

Foothills Hospital — Calgary
University of Alberta Hospital — Edmonton
Medicine Hat Regional Hospital — Medicine Hat
East Kootenay Regional Hospital — Cranbrook
Fraser Health Authority — Surrey
Vancouver General Hospital — Vancouver
Health Sciences Centre Winnipeg — Winnipeg
Dr.-Georges-L.-Dumont University Hospital Centre — Moncton
… и ещё 16 центров

Австралия · 14 центров

Canberra Hospital — Garran
Bankstown Hospital — Bankstown
Royal Prince Alfred Hospital — Camperdown
Concord Repatriation General Hospital — Concord
Liverpool Hospital — Liverpool
John Hunter Hospital — Newcastle
Westmead Hospital — Westmead
Sunshine Coast Hospital and Health Service — Birtinya
… и ещё 6 центров

Нидерланды · 12 центров

Jeroen Bosch Hospital — 's-Hertogenbosch
Noordwest Ziekenhuisgroep — Alkmaar
ZiekenhuisGroepTwente (ZGT) — Almelo
Ziekenhuis Amstelland — Amstelveen
Rijnstate Hospital — Arnhem
Amphia Ziekenhuis Breda — Breda
Deventer Ziekenhuis — Deventer
Hospital Gelderse Vallei — Ede
… и ещё 4 центра

Индия · 10 центров

GNRC Medical — North Guwāhāti
Marengo CIMS Hospital — Ahmedabad
NU Hospitals — Bangalore
Govt. T.D. Medical College — Alappuzha
Amala Institute of Medical Sciences — Thrissur
Amala Institute — Thrissur
St. John's Medical College Hospital — Bangalore
JIPMER — Puducherry
… и ещё 2 центра

Аргентина · 7 центров

Clinica Coronel Suarez — Coronel Suárez
Instituto de Investigaciones Clinicas Rosario — Rosario
Instituto Cardiovascular de Rosario — Rosario
Centro Integral de Arritmias de Tucuman (CIAT) — San Miguel de Tucumán
Hospital Municipal Chivilcoy — Chivilcoy
Sanatorio Cisma — San Miguel de Tucumán
Hospital Privado de Rosario — Santa Fe

Испания · 6 центров