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
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 4, 2017
CompletedFirst Posted
Study publicly available on registry
September 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedSeptember 13, 2017
August 1, 2017
1 year
September 4, 2017
September 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of the global cognitive performance between geriatric patients exposed and non-exposed to VKA
Global cognitive performance is assessed by the Mini-Mental State Examination (MMSE) score
Baseline
Secondary Outcomes (3)
Comparison of moderate-to-severe dementia diagnosis between geriatric patients exposed and non-exposed to VKA
Baseline
Comparison of the executive functions between geriatric patients exposed and non-exposed to VKA
Baseline
Evaluation of the volume of vascular calcifications in the brain according to the use of VKAs
Baseline
Study Arms (2)
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
Eligibility Criteria
Patients are recruited in the memory clinic and geriatric day hospital of the University Hospital of Angers, France
You may qualify if:
- 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
You may not qualify if:
- Severe kidney failure (creatinine clearance \< 30 mL/min)
- Language other than French
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Angers University Hospital
Angers, 49933, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2017
First Posted
September 8, 2017
Study Start
September 1, 2017
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
September 13, 2017
Record last verified: 2017-08