AntiCoagulants and COGnition

• Status: Not yet recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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 versus a vitamin K antagonist (warfarin).

The secondary objectives are to compare, among participants with NVFA receiving rivaroxaban versus warfarin :

• the changes of global cognitive performance after 26 weeks of intervention

• the changes of executive functions after 26 and 52 weeks of intervention

• the changes of episodic memory after 26 and 52 weeks of intervention

• the volumetric changes of the brain after 26 and 52 weeks of intervention

• the changes of independence and autonomy after 26 and 52 weeks of intervention

• the changes of serum vitamin K concentration after 26 and 52 weeks of intervention

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Angers
• Collaborator: Bayer
• Treatments: Anticoagulants; Rivaroxaban; Warfarin

Criteria

Inclusion Criteria:

• 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 ≥ 25

• Subjects who can give written consent to participate in the study

• Affiliation to a social security scheme.

Exclusion Criteria:

• Known history of stroke and/or a diagnosed condition of dementia (DSM-IV criteria) and/or severe depressive symptomatology (score on the 15-item Geriatric Depression Scale > 10)

• Moderate or severe mitral stenosis

• Conditions other than NVAF that require anticoagulation

• Use of anticoagulant 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

• Any contraindication to MRI

• 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