check_circleStudy Completed

Anticoagulation

Bayer Identifier:

16167

ClinicalTrials.gov Identifier:

NCT01907048

EudraCT Number:

Not Available

EU CT Number:

Not Available
Patient and Physician Knowledge of Key Safety Messages

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.

Trial summary

Enrollment Goal
2227
Trial Dates
September 2014 - April 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, United Kingdom
Completed
Many Locations, Germany
Completed
Many Locations, France
Completed
Many Locations, Spain

Primary Outcome

  • Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaire
    date_rangeTime Frame:
    Up to 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Knowledge and understanding of patients regarding the key safety information contained in the patient alert card assessed by paper-based questionnaire
    date_rangeTime Frame:
    Up to 18 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages
Trial Type
Observational
Intervention Type
Behavioral
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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