Study identification

EU PAS number

EUPAS9977

Study ID

35313

Official title and acronym

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 (ROSE ACS)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

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 followup 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.

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Saad Shakir

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer Pharma AG
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)