Nonvalvular Atrial Fibrillation Clinical Trial
— ACCOGOfficial title:
AntiCoagulants and COGnition (ACCOG Trial): a Single-blind Randomized Controlled Trial Comparing the Neurocognitive Effects of Rivaroxaban Versus Vitamin K Antagonist
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 changes of independence and autonomy after 26 and 52 weeks of intervention
Status | Recruiting |
Enrollment | 48 |
Est. completion date | February 2023 |
Est. primary completion date | February 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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 = 20 - 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 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 |
Country | Name | City | State |
---|---|---|---|
France | Angers University Hospital | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers | Bayer |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in global cognitive performance | Global cognitive performance is assessed with Alzheimer's Disease Assessment Scale-cognition score (ADAS-cog).
Total scores range from 0-70, with higher scores (= 18) indicating greater cognitive impairment. |
This outcome is assessed at baseline, 26 and 52 weeks after inclusion. | |
Secondary | Change in executive functions | Executive functions are assessed with Frontal Assessment Battery score (FAB). | This outcome is assessed at baseline, 26 and 52 weeks after inclusion. | |
Secondary | Change in executive functions | Executive functions are assessed with digit spans. | This outcome is assessed at baseline, 26 and 52 weeks after inclusion. | |
Secondary | Change in executive functions | Executive functions are assessed with Trail Making Tests (TMT) parts A and B. | This outcome is assessed at baseline, 26 and 52 weeks after inclusion. | |
Secondary | Change in executive functions | Executive functions are assessed with Stroop test. | This outcome is assessed at baseline, 26 and 52 weeks after inclusion. | |
Secondary | Change in executive functions | Executive functions are assessed with the Processing Speed Index. | This outcome is assessed at baseline, 26 and 52 weeks after inclusion. | |
Secondary | Change in episodic memory | Episodic memory is assessed with Five-word test. The 5-word test studies the recall of a short list. The score of the first immediate recall and the score of the delayed recall should normally be equal to 10. | This outcome is assessed at baseline, 26 and 52 weeks after inclusion. | |
Secondary | Change in independence and autonomy | Independence and autonomy are assessed with Activities of Daily Living (ADL) score.
ADL is an autonomy assessment grid (from 0 to 6) for basic activities of daily living (ADL). The lower the score, the more dependent the patient is. |
This outcome is assessed at baseline, 26 and 52 weeks after inclusion. | |
Secondary | Change in independence and autonomy | Independence and autonomy are assessed with the 4-item Instrumental Activities of Daily Living (IADL-PAQUID) score.
This test is used to assess the level of dependence in instrumental activities of daily living. The scale ranges from 0 to 4, with 0 indicating total dysautonomy and 4 indicating a totally autonomous person. |
This outcome is assessed at baseline, 26 and 52 weeks after inclusion. |
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