Patient and Physician Knowledge of Key Safety Messages

This cross-sectional epidemiologic study measured physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.

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Key information

Conditions

Anticoagulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria:

Physician eligibility:

Prescription of rivaroxaban in the past 6 months for adult patients for the Prevention of stroke and systemic embolism with non-valvular atrial fibrillation (SPAF) or Treatment of deep venous thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT.

Patient eligibility:

Use of rivaroxaban for SPAF or DVT within the previous 3 months; aged 18 years and above; able to understand and complete the consent form and patient questionnaire.

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Behavioral

Survey to measure physician awareness and understanding of the key messages in the prescriber guide.

Primary outcomes

Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaire

Time frame: Up to 18 months
Knowledge and understanding of patients regarding the key safety information contained in the patient alert card assessed by paper-based questionnaire

Time frame: Up to 18 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

Janssen Research & Development, LLC
RTI Health Solutions

Registry information

Official study title

Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Jul 24, 2013
Registry last updated: Apr 8, 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.

Published trials that share one or more normalized conditions with this study.

Completed