An observational post-authorization Modified Prescription-Event Monitoring safety study to monitor the safety and utilization of rivaroxaban (XARELTO®) for the prevention of stroke in patients with AF, treatment of DVT and PE, and prevention of recurrent DVT and PE following an acute DVT in the primary care setting in England, extended to include Acute Coronary Syndrome Patients (Rivaroxaban MPEM)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28575
• EU PAS number:
  EUPAS15961
• Study ID:
  28575
• Official title and acronym:
  An observational post-authorization Modified Prescription-Event Monitoring safety study to monitor the safety and utilization of rivaroxaban (XARELTO®) for the prevention of stroke in patients with AF, treatment of DVT and PE, and prevention of recurrent DVT and PE following an acute DVT in the primary care setting in England, extended to include Acute Coronary Syndrome Patients (Rivaroxaban MPEM)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Rivaroxaban is a highly selective direct factor Xa inhibitor which inhibits thrombin formation and the development of thrombi. This M-PEM study will enable the systematic collection and reporting of drug utilisation and safety data on patients newly initiated on treatment with rivaroxaban in the primary care setting. The study aims to collect exposure and outcome data for a cohort of approximately 10,000 evaluable patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Drug Safety Research Unit (DSRU)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 19/01/2012

Actual: 19/01/2012

Study start date

Planned: 01/12/2011

Actual: 31/01/2012

Data analysis start date

Planned: 01/06/2017

Actual: 01/06/2017

Date of interim report, if expected

Planned: 29/11/2013

Actual: 03/12/2013

Date of final study report

Planned: 28/02/2018

Actual: 27/10/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer

Study protocol

Initial protocol

Rivaroxaban_M_PEM_ Full_Protocol_FINAL_ACS_extension_16_04_2015

Updated protocol

Rivaroxaban_M_PEM_ Full_Protocol_FINAL_PASS_v6_17_04_2015

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)