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Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation (ASPIRIN-LAAO)

9 de octubre de 2021 actualizado por: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin after left atrial appendage occlusion (LAAO).

Patients diagnosed with atrial fibrillation and have undergone LAAO will be enrolled in this study. Randomization will be performed at 6 months post-implant. The randomization program electronically assigns the patient 1:1 to either the Aspirin group or the control group. Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day). The control group receives placebo. After the randomization, subjects of both groups will have follow-up visits at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment. For each group, 560 patients will be included, with an estimated total number of 1120 participants in this clinical study. Patients will be followed up until 24 months after the last enrollment.

The primary endpoint is a composite consisting of stroke, systemic embolism, cardiovascular or unexplainable death, acute coronary syndrome, coronary artery disease or periphery vascular disease requiring revascularization and major bleeding. The secondary endpoints are all-cause death, device related thrombus, minor bleeding and rehospitalization due to heart failure.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin since the sixth month after LAAO.

Patients diagnosed with paroxysmal or persistent atrial fibrillation with an age between 18 and 90 years and have undergone LAAO will be enrolled in this study. Randomization will be performed at 6 months post-implant. The randomization program electronically assigns the patient 1:1 to either the Aspirin group or the control group. Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day). The control group receives placebo. After the randomization, subjects of both groups will have follow-up visits at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment. For each group, 560 patients will be included, with an estimated total number of 1120 participants in this clinical study. Patients will be followed up until 24 months after the last enrollment.

The primary endpoint is a composite consisting of stroke, systemic embolism, cardiovascular or unexplainable death, acute coronary syndrome, coronary artery disease or periphery vascular disease requiring revascularization and major bleeding. The secondary endpoints are all-cause death, device related thrombus, minor bleeding and rehospitalization due to heart failure.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

1120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Porcelana
    • Shanghai
      • Shanghai, Shanghai, Porcelana, 200092
        • Reclutamiento
        • Xinhua Hospital, School of Medicne, Shanghai Jiao Tong University
        • Contacto:
        • Investigador principal:
          • Yi-Gang Li, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age between 18 and 90 years
  • Paroxysmal, persistent, long-standing persistent or permanent nonvalvular AF
  • Have already had a Watchman LAAO device implanted 6 months ago

Exclusion Criteria:

Clinical Exclusion Criteria

  • Long-term aspirin therapy required
  • Including coronary artery disease, symptomatic carotid disease, prior myocardial infarction, strokes or systemic embolism, etc
  • Contraindicated for aspirin therapy
  • Including active peptic ulcer, thrombocytopenia or anemia, etc.
  • Uncontrolled malignant tumor
  • Abnormal liver, renal or coagulation function
  • Pregnant or pregnancy is planned during the course of the investigation
  • Terminal illness with life expectancy <1 year
  • Enrolled in another IDE or IND investigation of a cardiovascular device or an investigational drug

TEE Exclusion Criteria*

  • Peri-device leak >5mm
  • Device-related thrombus
  • Other intracardiac thrombus

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Aspirin group
Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day).
Droga: Aspirin Tablet
Aspirin 100mg qd
Comparador de placebos: Control group
Study patients assigned to control group will receive placebo.
Droga: Placebo
Placebo qd

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants with stroke
Periodo de tiempo: 24 months after the date of randomization.
A stroke is a medical condition in which poor blood flow to the brain results in cell death. There are two main types of stroke: ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding. They result in part of the brain not functioning properly. Signs and symptoms of a stroke may include an inability to move or feel on one side of the body, problems understanding or speaking, dizziness, or loss of vision to one side. If symptoms last less than one or two hours it is known as a transient ischemic attack (TIA) or mini-stroke. A hemorrhagic stroke may also be associated with a severe headache. The symptoms of a stroke can be permanent. Brain computed tomography or MRI may help diagnose stroke.
24 months after the date of randomization.
Number of participants with systemic embolism
Periodo de tiempo: 24 months after the date of randomization.

An embolism is the lodging of an embolus, a blockage-causing piece of material, inside a blood vessel. The embolus is usually a blood clot (thrombus). An embolism can cause partial or total blockage of blood flow in the affected vessel.

An embolism in which the embolus is a piece of thrombus is called a thromboembolism.

An embolism is usually a pathological event, i.e., accompanying illness or injury. Sometimes it is created intentionally for a therapeutic reason, such as to stop bleeding or to kill a cancerous tumor by stopping its blood supply.

Embolism can be classified as to where it enters the circulation either in arteries or in veins. Arterial embolism are those that follow and, if not dissolved on the way, lodge in a more distal part of the systemic circulation.
24 months after the date of randomization.
Number of participants with cardiovascular/unexplained death
Periodo de tiempo: 24 months after the date of randomization.
Cardiovascular deaths refer to deaths due to heart dysfunction, injury of cardiac structure, coronary artery diseases and lethal arrhythmias or sudden death that cannot be explain. Cardiovascular deaths can be diagnosed with clinical symptoms or from the results of diagnostic examinations.
24 months after the date of randomization.
Number of participants with major bleedings
Periodo de tiempo: 24 months after the date of randomization.
Major bleedings refer to the heavy bleedings of the mains organs of the body, usually include intracranial bleeding and gastrointestinal bleeding et al.. Brain computed tomography and gastrointestinal endoscope are the common approaches for diagnosing major bleedings.
24 months after the date of randomization.
Number of participants with acute coronary syndrome
Periodo de tiempo: 24 months after the date of randomization.

Acute coronary syndrome is a syndrome (set of signs and symptoms) due to decreased blood flow in the coronary arteries such that part of the heart muscle is unable to function properly or dies. The most common symptom is chest pain, often radiating to the left shoulder or angle of the jaw, crushing, central and associated with nausea and sweating. Many people with acute coronary syndromes present with symptoms other than chest pain, particularly, women, older patients, and patients with diabetes mellitus.

Acute coronary syndrome is commonly associated with three clinical manifestations, named according to the appearance of the electrocardiogram (ECG): ST elevation myocardial infarction (STEMI, 30%), non-ST elevation myocardial infarction (NSTEMI, 25%), or unstable angina (38%). There can be some variation as to which forms of myocardial infarction (MI) are classified under acute coronary syndrome.
24 months after the date of randomization.
Number of participants with coronary or periphery artery disease requiring revascularization
Periodo de tiempo: 24 months after the date of randomization.
Conronary or periphery artery diseases, regardless stable or not, need revascularization by stent which require long-term aspirin therapy
24 months after the date of randomization.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants with device-related thrombus
Periodo de tiempo: 24 months after the date of randomization.
This refers to the thrombus that is related to the implantation of the device for left atrial appendage closure. Transesophageal echocardiography is effective in identifying and diagnosing device-related thrombus.
24 months after the date of randomization.
Number of participants with minor bleedings
Periodo de tiempo: 24 months after the date of randomization.
Minor bleedings refer to the bleedings acoording to the TIMI cirteria
24 months after the date of randomization.
Number of Participants with hospitalization due to heart failure
Periodo de tiempo: 24 months after the date of randomization.
Patients need to receive treatments in hospital because of occurrence of heart failure or deterioration of heart failure.
24 months after the date of randomization.
Number of participants with all-cause death
Periodo de tiempo: 24 months after the date of randomization.
any cause of death
24 months after the date of randomization.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigadores

  • Investigador principal: Yi-Gang Li, Dr., Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2020

Finalización primaria (Anticipado)

1 de junio de 2022

Finalización del estudio (Anticipado)

1 de diciembre de 2024

Fechas de registro del estudio

Enviado por primera vez

22 de enero de 2019

Primero enviado que cumplió con los criterios de control de calidad

27 de enero de 2019

Publicado por primera vez (Actual)

30 de enero de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de octubre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

9 de octubre de 2021

Última verificación

1 de junio de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • XH-18-017

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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