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OpenTrials
Completed

NCT Number: NCT02422602

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

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.

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Key information

Conditions

Non-valvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart and vascular diseases service

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xarelto

Drug

Taking conventional charge

Experimental: Personalized information intervention

Other

Primary outcomes

  1. The occurence of serious adverse event

    Time frame: 12 months

    The occurence of serious adverse event

Secondary outcomes

  1. The number ok hospitalization

    Time frame: 12 months

    The number ok hospitalization

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: MONACO

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 21, 2015
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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