An 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 (ROSE)

Study identification

• EU PAS number:
  EUPAS3979
• Study ID:
  28398
• Official title and acronym:
  An 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 (ROSE)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Drug Safety Research Unit (DSRU)

United Kingdom

Networks

Stroke Research Network, Non-malignant Haematology Group, Cardiovascular Group

Study timelines

Date when funding contract was signed

Planned: 19/12/2012

Actual: 19/12/2012

Study start date

Planned: 21/05/2013

Actual: 05/09/2013

Data analysis start date

Planned: 01/11/2016

Actual: 31/03/2017

Date of interim report, if expected

Planned: 13/04/2015

Actual: 13/08/2015

Date of final study report

Planned: 28/02/2017

Actual: 26/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer plc

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)