Status: Finalised First registered on: 22/05/2013
Last updated on: 22/02/2019
1. Study identification
EU PAS Register NumberEUPAS3979
Official titleAn Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto®) for the Prevention of Stroke in Patients with AF, Treatment of DVT and PE, and the Prevention of Recurrent DVT and PE in the Secondary Care Hospital Setting in England and Wales
Study title acronymROSE
Study typeObservational study
Brief description of the studyA study to evaluate the use and short term safety of Rivaroxaban (Xarelto®) during real-life use in Secondary Care (hospitals) in England and Wales. Rivaroxaban is an anti-coagulant medication which has previously been used only in patients having hip or knee replacement surgery but will now also be used to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation. Rivaroxaban will also be used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) and to prevent recurrent DVT and PE. This study aims to evaluate the use of rivaroxaban and its short term safety when used by patients for these new indications. This study was requested by the Committee for Medicinal products for Human use (CHMP). The study will recruit patients starting rivaroxaban treatment and asking their care team to answer some simple questions about them at the time they start and again in 12 weeks time. The study will also recruit patients starting alternative anticoagulant therapies and their care team will be asked the same questions. These patients will be used to compare the differences between users of rivaroxaban and users of alternative anticoagulant therapies. If a participant has an adverse event during the 12 week period, we may ask the patient’s care team to fill out a further follow up questionnaire. No other examinations or tests will be performed. The participant’s consent will be obtained to access their medical charts. Any adult patient started by their care team on rivaroxaban or an alternative anticoagulant for the specified indications during the study period will be eligible to take part. It is a national study covering the whole of England and Wales. The study will last for approximately 3 years of data collection (in order to reach a cohort of 3400 patients - 1700 rivaroxaban users and 1700 alternative anticoagulant therapy users), although each individual patient will only be involved for a 12 week period of observation.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
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?
Yes
Stroke Research Network
Non-malignant Haematology Group
Cardiovascular Group
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 signed19/12/201219/12/2012
Start date of data collection21/05/201305/09/2013
Start date of data analysis01/11/201631/03/2017
Date of interim report, if expected13/04/201513/08/2015
Date of final study report28/02/201726/06/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer plc100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Evans
First name Alison
Address line 1DSRU
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code) 
Email address alison.evans@dsru.org
Public Enquiries
Title Dr 
Last name Evans 
First name Alison 
Address line 1Drug Safety Research Unit 
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom 
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code) 
Email address alison.evans@dsru.org 
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