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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
-
-
-
Angers, Francie, 49933
- Angers University Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
Exposed to VKA
VKA intake Patients who have been taking VKA for at least 3 months
|
|
Non-exposed to VKA
DOAC intake Patients who have been taking DOAC for at least 3 months
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Comparison of the global cognitive performance between geriatric patients exposed and non-exposed to VKA
Časové okno: Baseline
|
Global cognitive performance is assessed by the Mini-Mental State Examination (MMSE) score
|
Baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Comparison of moderate-to-severe dementia diagnosis between geriatric patients exposed and non-exposed to VKA
Časové okno: Baseline
|
Moderate-to-severe dementia defined as a MMSE score < 20 / 30
|
Baseline
|
|
Comparison of the executive functions between geriatric patients exposed and non-exposed to VKA
Časové okno: Baseline
|
Executive functioning is assessed by the Frontal Assessment Battery (FAB) score
|
Baseline
|
|
Evaluation of the volume of vascular calcifications in the brain according to the use of VKAs
Časové okno: Baseline
|
Semi-automated measure of the volume of vascular calcifications in the brain based on CT scan
|
Baseline
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2017/19
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .