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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03276377
Other study ID # 2017/19
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 4, 2017
Last updated September 12, 2017
Start date September 2017
Est. completion date September 2018

Study information

Verified date August 2017
Source University Hospital, Angers
Contact Cedric ANNWEILER, MD, PhD
Phone ++33 2 41 35 54 86
Email cedric.annweiler@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Angers University Hospital Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Comparison of moderate-to-severe dementia diagnosis between geriatric patients exposed and non-exposed to VKA Moderate-to-severe dementia defined as a MMSE score < 20 / 30 Baseline
Secondary Comparison of the executive functions between geriatric patients exposed and non-exposed to VKA Executive functioning is assessed by the Frontal Assessment Battery (FAB) score Baseline
Secondary Evaluation of the volume of vascular calcifications in the brain according to the use of VKAs Semi-automated measure of the volume of vascular calcifications in the brain based on CT scan Baseline
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