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NCT02422602 Clinical Trial

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

Non-valvular Atrial Fibrillation Clinical Trial

— MONACO  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02422602
Other study ID # 9120
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 26, 2013
Est. completion date May 6, 2016

Study information
Verified date April 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 196
Est. completion date May 6, 2016
Est. primary completion date May 6, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Xarelto
Taking conventional charge
Other:
• Experimental: Personalized information intervention

Locations
Country Name City State
France Heart and vascular diseases service Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary The occurence of serious adverse event The occurence of serious adverse event 12 months
Secondary The number ok hospitalization The number ok hospitalization 12 months
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