Rivaroxaban registries
- We were approached by the Marketing Authorisation Holder to conduct a Post-authorisation Safety Study (PASS) of rivaroxaban use in routine clinical practice as part of their European epidemiological PASS programme.
- The DSRU proposed two registry-based observational cohort studies with a contextual cohort, utilising the technique of Specialist Cohort Event Monitoring (SCEM): ROSE (Rivaroxaban Observational Safety Evaluation) and ROSE-ACS (Acute Coronary Syndrome).
- Both studies were conducted in a secondary care setting in England and Wales with the support of the UK National Institute for Health Research Clinical Research Networks to facilitate recruitment and achieve a high response rate.
- The primary objective was to determine the risk of major bleeding during a 12-week observation period, according to the International Society on Thrombosis and Haemostasis (ISTH) and Thrombolysis in Myocardial Infarction (TIMI) definitions.
- The unique aspects of this study design enabled the rapid identification of early prescribers and accumulation of an inception cohort, and collection of highly detailed, comprehensive and accurate information facilitating the application of clinical trial outcome definitions, in a real-world setting.
- Results from the ROSE study have been published here: DVT and PE paper and here: Stroke Prevention paper
- The ROSE ACS study has been published here