ROSE ACS Study
Research type
Research Study
Full title
An Observational Post-authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (XARELTO®) Initiated in Secondary Care for the Prevention of Atherothrombotic Events in Patients Who Have Had Acute Coronary Syndrome in England and Wales
IRAS ID
162825
Contact name
Saad Shakir
Contact email
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
Rivaroxaban is a medicine which reduces the formation of blood clots. Acute coronary syndrome (ACS) comprises a range of disorders, including heart attack and unstable angina, caused by a sudden reduction in blood flow to part of the heart muscle. This study aims to collect information on the use of rivaroxaban and its safety when used by patients for the prevention of artherothrombotic (plaque rupture leading to a blood clot) events following ACS, during the first three months after starting. This study was requested by the European regulatory body (EMA) which is responsible for the use and safety of medicines. It will last for approximately 3 years and is a national study covering the whole of England and Wales.
The study aims to recruit 1193 patients who have been prescribed rivaroxaban and antiplatelet therapy and 1193 patients who have been prescribed alternative dual antiplatelet therapy for the secondary prevention of artherothrombotic events following ACS. Each patient will only be monitored for the first 13 weeks after hospital admission for ACS.
Patients who choose to take part will complete a consent form. The patient’s care team will be asked to complete a baseline questionnaire about the patient at the time the medicine is given and a further questionnaire up to 16 weeks later, specifically asking about the patient’s experiences whilst on the medication. If anything unusual is reported during the observation period, the care team may be asked to fill out a follow-up questionnaire. With the patient’s consent, the study team will also inform the patient’s GP of their participation in the study and will ask the GP to complete an abridged questionnaire from the patient’s medical records.
The study team will analyse and aggregate the data, carefully protecting patient confidentiality, to classify adverse events of interest, in particular bleeding events.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0199
Date of REC Opinion
12 Jun 2015
REC opinion
Further Information Favourable Opinion