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Patient and Physician Knowledge of Key Safety Messages

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01907048
Enrollment
2227
Registered
2013-07-24
Start date
2014-09-15
Completion date
2020-04-15
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulation

Keywords

Survey, Effectiveness of risk minimization measures, Rivaroxaban, Anticoagulants

Brief summary

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.

Interventions

BEHAVIORALRivaroxaban (Xarelto, BAY59-7939)

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

Sponsors

Janssen Research & Development, LLC
CollaboratorINDUSTRY
RTI Health Solutions
CollaboratorOTHER
Bayer
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- 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.

Design outcomes

Primary

MeasureTime frame
Knowledge and understanding of patients regarding the key safety information contained in the patient alert card assessed by paper-based questionnaireUp to 18 months
Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaireUp to 18 months

Countries

France, Germany, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026