Status: Finalised First registered on: 25/10/2016
Last updated on: 27/02/2019
1. Study identification
EU PAS Register NumberEUPAS15961
Official titleAn 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
Study title acronymRivaroxaban MPEM
Study typeObservational study
Brief description of the studyRivaroxaban 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsDSRU
Department/Research group
Organisation/affiliationDrug Safety Research Unit
Website/Homepagewww.dsru.org
Details of (Primary) lead investigator
Title Professor
Last name Shakir
First name Saad
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/01/201219/01/2012
Start date of data collection01/12/201131/01/2012
Start date of data analysis01/06/201701/06/2017
Date of interim report, if expected29/11/201303/12/2013
Date of final study report28/02/201827/10/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Lynn
First name Elizabeth
Address line 1Drug Safety Research Unit
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom
Phone number (incl. country code)442380408600 
Alternative phone number 
Fax number (incl. country code) 
Email address elizabeth.lynn@dsru.org
Public Enquiries
Title Dr 
Last name Lynn 
First name Elizabeth 
Address line 1Drug Safety Research Unit 
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom 
Phone number (incl. country code)442380408600 
Alternative phone number 
Fax number (incl. country code) 
Email address elizabeth.lynn@dsru.org 
Top