VItamin K Inhibition and NeurocoGnition (VIKING) (VIKING)
Use of Vitamin K Antagonist and Neurocognitive Disorders in Older Adults : a Retrospective Study With Exposed and Non-exposed Groups
The primary objective of this study is to determine whether patients usually taking Vitamin K Antagonists (VKAs) exhibit a poorer global cognitive performance than control patients (matched on age, gender and indication for anticoagulation) taking direct oral anticoagulants (DOACs).
The secondary objectives are:
- to determine whether patients usually taking VKAs are more likely to have moderate to severe cognitive disorders than matched controls taking DOACs.
- to determine whether VKAs intake is associated with poorer executive functions.
- to determine on CT scans whether the VKAs intake is associated with a greater volume of vascular calcifications in the brain compared to the use of DOACs.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
VKAs are the most common drugs in the treatment and prophylaxis of thromboembolic events in older adults. Their action is mediated by decrease in the bioavailability of the active form of vitamin K. However, vitamin K participates in brain health and function by regulating the synthesis of sphingolipids, a constituent of the myelin sheath and the neurons membrane, and through the biological activation of vitamin K-dependent proteins (VKDPs) involved in neuron survival. Epidemiological studies have reported a positive association between higher serum vitamin K concentration and better verbal episodic memory performance in older adults, and an inverse association between dietary vitamin K intakes and cognitive complaint/cognitive disorders/behavioral disorders. VKAs, which deplete the active form of vitamin K, may thus be responsible for neurological disorders. CNS abnormalities were observed in newborns exposed in utero to VKA. Similarly, in two cross-sectional studies, the use of VKAs was directly associated with cognitive disorders in older adults, and with a lower volume of gray matter in the hippocampus.
However, the main limitation of these previous studies was that the different associations reported may actually be explained by the thromboembolic pathology justifying the use of VKA such as atrial fibrillation with potential adverse consequences on the brain.
Thus, the use of DOACs could serve as an ideal comparator, as their indications are similar to those of VKAs but which mechanism does not interfere with vitamin K.
The investigators hypothesize that 1) geriatric patients usually taking VKAs may have lower cognitive performance than those usually taking DOACs; 2) there is an association between VKA intake and cognitive performance in geriatric patients, including after adjustment on the indication for anticoagulation; and 3) that geriatric patients usually taking VKAs exhibit brain changes compared to those usually taking DOACs, including greater calcification burden.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cedric ANNWEILER, MD, PhD
- Número de teléfono: ++33 2 41 35 54 86
- Correo electrónico: cedric.annweiler@chu-angers.fr
Ubicaciones de estudio
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Angers, Francia, 49933
- Angers University Hospital
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Contacto:
- Cedric ANNWEILER, MD, PhD
- Número de teléfono: ++33 2 41 35 54 86
- Correo electrónico: cedric.annweiler@chu-angers.fr
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Investigador principal:
- Antoine BRANGIER, MD, BS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age 70 years and over
- To be seen in consultation or day hospital in the department of geriatrics from 01/01/2015 to 31/12/2016
Exposed :
- Patients who have been taking VKA for at least 3 months for atrial fibrillation or pulmonary embolism, with INR between 2 and 3
Non-exposed:
- Patients who have been taking DOAC for at least 3 months for atrial fibrillation or pulmonary embolism
- Matched on age (± 5 years), gender and indication for anticoagulation
Exclusion Criteria:
- Severe kidney failure (creatinine clearance < 30 mL/min)
- Language other than French
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Exposed to VKA
VKA intake Patients who have been taking VKA for at least 3 months
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Non-exposed to VKA
DOAC intake Patients who have been taking DOAC for at least 3 months
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comparison of the global cognitive performance between geriatric patients exposed and non-exposed to VKA
Periodo de tiempo: Baseline
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Global cognitive performance is assessed by the Mini-Mental State Examination (MMSE) score
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comparison of moderate-to-severe dementia diagnosis between geriatric patients exposed and non-exposed to VKA
Periodo de tiempo: Baseline
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Moderate-to-severe dementia defined as a MMSE score < 20 / 30
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Baseline
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Comparison of the executive functions between geriatric patients exposed and non-exposed to VKA
Periodo de tiempo: Baseline
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Executive functioning is assessed by the Frontal Assessment Battery (FAB) score
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Baseline
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Evaluation of the volume of vascular calcifications in the brain according to the use of VKAs
Periodo de tiempo: Baseline
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Semi-automated measure of the volume of vascular calcifications in the brain based on CT scan
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Baseline
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2017/19
Información sobre medicamentos y dispositivos, documentos del estudio
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