Resumen

Estudio multinacional iniciado por investigadores sobre anticoagulación oral versus ninguna anticoagulación para la prevención del accidente cerebrovascular y otros eventos cardiovasculares adversos en pacientes con fibrilación auricular transitoria que ocurre transitoriamente con estrés y factores de riesgo adicionales de accidente cerebrovascular.

Descripción detallada

ASPIRE-AF es un ensayo prospectivo, aleatorizado, abierto de anticoagulantes orales no antagonistas de la vitamina K (ACOD) versus ninguna anticoagulación oral en pacientes con fibrilación auricular transitoria y factores adicionales de accidente cerebrovascular que ocurren transitoriamente con estrés. El objetivo primario es evaluar los efectos de los ACOD frente a ninguna anticoagulación sobre los desenlaces compuestos coprimarios de: 1. accidente cerebrovascular no hemorrágico y embolia sistémica, y 2. mortalidad vascular, accidente cerebrovascular no fatal no hemorrágico, infarto de miocardio, trombosis arterial periférica, amputación y tromboembolismo venoso sintomático durante el período de seguimiento.

Elegibilidad

Edad mínima: 55 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

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.

Ubicaciones

Clinica Coronel Suarez

Coronel Suárez, Buenos Aires, Argentina

Alberto Caccavo, MD

RECRUITING

Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe Province, Argentina

Mariela Rasmussen, MD

RECRUITING

Instituto Cardiovascular de Rosario

Rosario, Santa Fe Province, Argentina

Alejandro Meirino, MD

RECRUITING

Centro Integral de Arritmias de Tucuman (CIAT)

San Miguel de Tucumán, Tucumán Province, Argentina

Maria Cecilia Moris, MD

RECRUITING

Hospital Municipal Chivilcoy

Chivilcoy, Argentina

Pablo Fernandez, MD

RECRUITING

Sanatorio Cisma

San Miguel de Tucumán, Argentina

Guillermo Isa Messa, MD

RECRUITING

Hospital Privado de Rosario

Santa Fe, Argentina

Carlos Dumont, MD

NOT_YET_RECRUITING

Anticoagulación para la prevención del accidente cerebrovascular en pacientes con episodios recientes de fibrilación auricular que ocurren transitoriamente con estrés - Ensayo ASPIRE-AF

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Non-vitamin K oral anticoagulant (NOAC)

Ubicaciones

Clinica Coronel Suarez

Instituto de Investigaciones Clinicas Rosario

Instituto Cardiovascular de Rosario

Centro Integral de Arritmias de Tucuman (CIAT)

Hospital Municipal Chivilcoy

Sanatorio Cisma

Hospital Privado de Rosario

Patrocinadores

Contactos

Cassie McDonald