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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40441
• EU PAS number:
  EUPAS3911
• Study ID:
  40441
• Official title and acronym:
  Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  United Kingdom
• Study description:
  This cross-sectional epidemiologic study will measure physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 16/12/2011

Study start date

Planned: 15/09/2014

Actual: 15/09/2014

Date of final study report

Planned: 10/06/2020

Actual: 18/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

16167_Xarelto_Protocol_Risk Minimization Study_Final_28Nov2011

Updated protocol

16167_Protocol_V4_Wave II_redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)