Drug Safety Research Unit
Southampton, Hampshire, SO31 1AA, United Kingdom
NCT Number: NCT01871194
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Southampton, Hampshire, SO31 1AA, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy
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.
Professor Saad Shakir
Other
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.
Acronym: ROSE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03682419
Antiphospholipid Syndrome, Arrhythmias, Cardiac
Glasgow, United Kingdom
View Trial DetailsNCT03894878
Arrhythmias, Cardiac, Atrial Fibrillation
Santa Clara, California, United States
View Trial DetailsNCT02032030
Angina, Angina Pectoris
St Louis, Missouri, United States
View Trial DetailsNCT02345356
Arrhythmias, Cardiac, Atrial Fibrillation
Miami, Florida, United States
View Trial Details