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AntiCoagulants and COGnition

NCT04073316 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-07-27

No results posted yet for this study

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

Interventions

DRUG

Rivaroxaban 20 MG

Rivaroxaban intake, 20mg/day

DRUG

Warfarin

Warfarin intake, with target INR range between 2 and 3

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • University Hospital, Angers

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04073316 on ClinicalTrials.gov