Status:
UNKNOWN
AntiCoagulants and COGnition
Lead Sponsor:
University Hospital, Angers
Collaborating Sponsors:
Bayer
Conditions:
Nonvalvular Atrial Fibrillation
Eligibility:
All Genders
70+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the change of global cognitive performance after 52 weeks of intervention among participants with nonvalvular atrial fibrillation (NVAF) receiving rivaroxaban v...
Detailed Description
Detailed Description: Vitamin K antagonists (VKAs) are commonly used for their role in hemostasis by interfering with vitamin K cycle decreasing the bioavailability of the vitamin K active form. In a...
Eligibility Criteria
Inclusion
- Men or women ≥ 70 years old
- Newly diagnosed hemodynamically stable NVAF longer than 52 hours or of unknown duration, and CHA2DS2-VASc score according to ESC 2016 guidelines for anticoagulation treatment indications
- MMSE score ≥ 20
- Subjects who can give written consent to participate in the study
- Affiliation to a social security scheme.
Exclusion
- Known history of stroke and/or a diagnosed condition of dementia (DSM-IV criteria) and/or severe depressive symptomatology (score on the 4-item Geriatric Depression Scale \> 3)
- Moderate or severe mitral stenosis
- Conditions other than NVAF that require anticoagulation
- Use of anticoagulant more than 3 days at inclusion or more than 15 days in the preceding 12 months
- Regular use of antiplatelet medications and/or nonsteroidal anti-inflammatory agents and/or azole class of antifungal agents and/or inhibitor of HIV protease
- Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
- Known presence of cardiac thombus or myxoma or valvular atrial fibrillation
- Any contraindication to anticoagulation, high risk of bleeding, and any other contraindication listed in the local labeling for the experimental treatment and comparator treatment
- Unstable health, severe hepatic failure, or severe and moderate renal failure (creatinine clearance \<50 mL/min), acute coronary syndromes
- Participation in another simultaneous clinical trial
- Inability to understand and speak French
- Refusal to participate from the participant
- Persons deprived of their liberty by administrative or judicial decision, persons under psychiatric care under duress, adults subject to a legal protection measure or unable to express their consent
Key Trial Info
Start Date :
February 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04073316
Start Date
February 13 2020
End Date
February 1 2023
Last Update
July 27 2022
Active Locations (1)
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1
Angers University Hospital
Angers, France, 49933 cedex 9