The Rivaroxaban Observational Safety Evaluation post-Acute Coronary Syndrome (ROSE ACS) Study
The ROSE ACS study is an observational post-authorisation safety specialist cohort event monitoring study (SCEM) to monitor the short term (first 3 months) safety and utilisation of Rivaroxaban (XARELTO®) prescribed for medical conditions requiring anticoagulation by specialists in secondary care in England and Wales. The study is being carried out by the Drug Safety Research Unit (DSRU), an independent registered medical charity.
Any patient in England and Wales will be eligible for inclusion in to the ROSE ACS study when a clinical decision to prescribe rivaroxaban (Xarelto®) plus antiplatelet therapy or dual antiplatelet therapy only is made as part of normal clinical practice for the secondary prevention of atherothrombotic events in adults after acute coronary syndrome (ACS). We would ask the prescriber or another HCP to enrol with the DSRU to include any eligible adult patients.
Following patient consent the specialist HCP or member of the care team will be asked to complete an initial questionnaire (Baseline questionnaire) after the medication has been started and then a second questionnaire (Outcome data questionnaire) at least 13 weeks after the patients hospital admission for ACS (questionnaires are downloadable from our website). If a participant has an adverse event during the 13 week observation period, we may ask the patient’s care team or the HCP responsible for the patient to fill out a further follow-up questionnaire. The questionnaires are largely tick-box style regarding patient demographics, past medical and drug history, antiplatelet or antiplatelet and anticoagulant regimen and any adverse events experienced. No other examinations or tests will be required to be performed.