Better Adherence With New Oral Anticoagulant in Atrial Fibrillation : Effectiveness of a Personalized Education Program

University Hospital, Montpellier1 site in 1 country196 target enrollmentNovember 26, 2013

ConditionsNon-valvular Atrial Fibrillation

InterventionsXarelto

DrugsXarelto

Overview

Phase: Not Applicable
Intervention: Xarelto
Conditions: Non-valvular Atrial Fibrillation
Sponsor: University Hospital, Montpellier
Enrollment: 196
Locations: 1
Primary Endpoint: The occurence of serious adverse event
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is multicentric, single-blind, and interventional with a randomization into two parallel arm, between a standard of care information and an additional information of the patient, with a 12 month follow up.

The aim of this study is to evaluate the effectiveness of a personalized information program versus information provided from standard of care in patients taking Xarelto for Stroke Prevention in Atrial Fibrillation.

Registry

clinicaltrials.gov

Start Date

November 26, 2013

End Date

May 6, 2016

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Montpellier

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All patients treated with rivaroxaban chronically, (atrial fibrillation non-valvular under current AMM) for less than one year whatever anti vitamin K treatment history
•Affiliate or beneficiary of a social security system.
•Patient who formulated its "does not oppose" to participate in this research
•Age higher than or equal to 18 years

Exclusion Criteria

•Opposition to participation
•Patient don't understand french language
•Patient does not have responsibility for the management of treatment (treatment administered by a nurse at home, or by caregivers)
•Tutorship or curatoship
•Law-protected patient
•Pregnant women or breast-feeding

Arms & Interventions

Taking conventional charge

No further information is given to the patient during the first and only contact with the nurse of the coordinator center. A time will be dedicated by the IDE to answer questions of the patient.

Intervention: Xarelto