AntiCoagulants and COGnition (NCT04073316) | Clinical Trial Compass
UnknownPhase 4
AntiCoagulants and COGnition
France48 participantsStarted 2020-02-13
Plain-language 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 changes of independence and autonomy after 26 and 52 weeks of intervention
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Inabili…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in global cognitive performance
Timeframe: This outcome is assessed at baseline, 26 and 52 weeks after inclusion.