An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto®). (ROSE)
January 26, 2018 updated by: Professor Saad Shakir
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 Atrial Fibrillation (AF), Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and the Prevention of Recurrent DVT and PE in the Secondary Care Hospital Setting in England and Wales.
This study aims to evaluate the use of rivaroxaban and its short term safety when used by patients for the new indications of prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE.
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.
A questionnaire will be completed by the care team of each patient at the start of treatment and again 12 weeks later.
The care team will complete the questionnaires using information from the patient's medical notes, not by asking the patient directly.
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.
Patients will only be recruited to the study after the clinical decision to prescribe rivaroxaban or an alternative anticoagulant has been made, so that prescribing behaviour is not altered by the study.
It is an observational, non-interventional study covering the whole of England and Wales.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
3400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hampshire
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Southampton, Hampshire, United Kingdom, SO31 1AA
- Drug Safety Research Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients prescribed rivaroxaban or an alternative anticoagulant in the secondary care hospital setting in England and Wales for the prevention of stroke in patients with AF, the treatment of DVT or PE, or the prevention of recurrent DVT and PE.
Description
Inclusion Criteria:
- age 18 years or above after study start
- index date on or after study start
- signed, informed consent
- patients treated for DVT or PE
- patients with non-valvular AF (with one or more risk factors) treated for prevention of stroke and systemic embolism
Exclusion Criteria:
- any use of univalent direct thrombin inhibitor or direct factor Xa inhibitors
- use of anticoagulant therapy or other vitamin K antagonists recorded within one year prior to index date
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Rivaroxaban
This is a non-interventional study
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Alternative anticoagulant therapy
This is a non-interventional study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cumulative incident risk of haemorrhage within gastrointestinal and urogenital organ sites (which meets the criteria for a major bleed) and all intracranial sites.
Time Frame: During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy
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The cumulative incidence will be calculated according to the formula: Total number of new cases during 12 week observation period x 100 / Population initially at risk If the observed cumulative incidence from this study falls within the range expected as set by the precision limits of cumulative incidence from clinical trial data, then the null hypothesis (of no difference) will not be rejected. |
During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
May 29, 2013
First Submitted That Met QC Criteria
June 4, 2013
First Posted (Estimate)
June 6, 2013
Study Record Updates
Last Update Posted (Actual)
January 30, 2018
Last Update Submitted That Met QC Criteria
January 26, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROSE
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