AntiCoagulants and COGnition

NCT04073316 | Unknown Phase 4

• 1 other identifier: 2019-000794-23
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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

Conditions

Nonvalvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in executive functions

  This outcome is assessed at baseline, 26 and 52 weeks after inclusion.

• Change in executive functions

  This outcome is assessed at baseline, 26 and 52 weeks after inclusion.

• Change in executive functions

  This outcome is assessed at baseline, 26 and 52 weeks after inclusion.

• Change in executive functions

  This outcome is assessed at baseline, 26 and 52 weeks after inclusion.

• Change in executive functions

  This outcome is assessed at baseline, 26 and 52 weeks after inclusion.

Study Arms (2)

"Intervention" group

EXPERIMENTAL

Drug: Rivaroxaban 20 MG

"Control" group

ACTIVE COMPARATOR

Drug: Warfarin

Interventions

Rivaroxaban 20 MG DRUG

Rivaroxaban intake, 20mg/day

"Intervention" group

Warfarin DRUG

Warfarin intake, with target INR range between 2 and 3

"Control" group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Angers: lead
• Bayer: collaborator

Study Sites (1)

Angers University Hospital

Angers, 49933 cedex 9, France

RECRUITING

MeSH Terms

Interventions

Rivaroxaban; Warfarin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Cédric ANNWEILER, MD, PhD

CONTACT

+33 2 41 35 54 86; cedric.annweiler@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 29, 2019
• Study Start: February 13, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

FR (1)