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

Not Applicable

Completed

• Conditions: Non-valvular Atrial Fibrillation
• Interventions: Drug: Xarelto

• Registration Number: NCT02422602
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-26
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-21
• Primary Completion: 2015-05-06
• Study Completion: 2016-05-06
• Status Verified: 2020-04
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taking conventional charge	Xarelto	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.

Primary Outcome Measures

Name	Time	Method
The occurence of serious adverse event	12 months	The occurence of serious adverse event

Secondary Outcome Measures

Name	Time	Method
The number ok hospitalization	12 months	The number ok hospitalization

Trial Locations

Locations (1)

Heart and vascular diseases service; 🇫🇷 Montpellier, France