Information for Patients
You are being invited to take part in a research study. This is a safety study and not a clinical trial. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with friends and relatives if you wish. Please ask us if there is anything that is not clear or if you would like more information.
What is Acute Coronary Syndrome (ACS)?
ACS can be caused by a blood clot that forms within a blood vessel in the heart. This can lead to either chest pain (angina) or a heart attack, and requires immediate hospital admission.
The purpose of the study
Rivaroxaban (Xarelto®) is a relatively newly introduced medication which reduces the formation of blood clots. It is used for the following:
• To prevent further blood clots in patients who have already had ACS. It would be used in combination with other blood thinning agents (antiplatelet therapy)
• To prevent blood clots in the brain or in other blood vessels in the body in patients with an irregular heart beat
• To prevent and treat blood clots in the legs and lungs
All drugs undergo extensive study before being made available on the market. In addition, all new drugs undergo routine surveillance by the regulatory body that is responsible for the use and safety of medicines in the UK. This study aims to collect more information on the use of rivaroxaban and its safety when used by patients following ACS, for the first three months after starting. This study was requested by the European regulatory body (the EMA) which is responsible for the use and safety of medicines. It will last for approximately three years and is a national study covering the whole of England and Wales.
Who can take part?
Any patient aged 18 years or more who is started by their consultant care team on rivaroxaban and antiplatelet therapy (e.g. clopidogrel, aspirin) or dual antiplatelet therapy without rivaroxaban will be eligible to take part. Not everyone that participates in the study will be prescribed rivaroxaban; you may have been prescribed aspirin and clopidogrel, for example. Each patient will only be monitored for the first 13 weeks after hospital admission for ACS.
Why have you been chosen?
You have been chosen because your care team have decided, based on their clinical opinion, that either rivaroxaban and antiplatelet therapy or dual antiplatelet therapy only is the most appropriate treatment for your condition.
What is the difference between the ROSE study and the ROSE-ACS study?
You may have heard of the ROSE study or know somebody involved in it. This is another study conducted by the DSRU that monitors the use and safety of rivaroxaban in patients compared to warfarin. The ROSE study focuses on patients who have been prescribed rivaroxaban, at higher doses (for example,15mg twice daily), for the prevention or treatment of blood clots in other parts of the body. ROSE ACS, however, will only involve patients who have been prescribed rivaroxaban, at a lower dose (2.5mg twice daily), plus antiplatelet therapy or dual antiplatelet therapy for the prevention of blood clots in the heart following an ACS event.
Do you have to take part?
It is up to you to decide whether or not to take part once you have read this sheet, spoken to your care team and/or seen or spoken to a member of our study team. This will not affect the medical care and treatment that you receive. If you do decide to take part you will keep this information sheet and be asked to complete and sign a consent form. You are still free to withdraw at any time by writing to your specialist or the study research team without giving a reason and your medical care will not be affected.
Do you have to decide right now?
No. You may take away this documentation and think about it. If you do, we only ask that you complete and sign the ‘Consent to Contact’ form and return it to a member of your care team. This form does not commit you in any way to take part in the study, but allows the study research staff to contact you within the next few days to ask for your decision. This will be the ONLY time that you will be contacted directly by the research staff in this study. There is a telephone number you can ring ((023) 8040 8600) or you can email any queries to: email@example.com during this time.
What will happen to you if you take part?
If you choose to take part and give your consent, we ask that you answer a few simple questions on the back of the consent form. The study team will also ask your care team to answer some simple questions about you (about the dose of medication you are taking, other medications you are taking or have taken, other illnesses you have or have had in the past, and your general health). This information will be obtained from your healthcare charts between the time you start your medication and 13 weeks later (specifically asking about your experiences whilst on the medication). If anything unusual is noted in your medical charts during that 13 week period, we may ask your care team to fill out a further follow-up questionnaire at a later date.
Will your GP be informed?
We would like to inform your GP that you are participating in the study, if you give your consent to do so. We can do this only if you provide your GP’s address on the consent form. We will also send your GP a short questionnaire to see if you are still taking the medication and if anything unusual was noted in your primary care medical charts.
Do you have to have any additional tests?
No other examinations or tests will be performed as part of this research. You will NOT be given any experimental treatment or medication as part of this study.
What do you do if you decide you don’t want to take part anymore?
You can contact your care team or the study research team at any time during the study (address below). This is best done in writing or by email. In the unlikely event of a loss of your present ability to provide informed consent, the research team will retain any data collected and continue to use it confidentially for this study.
Will your taking part in this study be kept confidential?
The information you give is entirely confidential and will not be disclosed to anyone outside the research team without your permission, although we will inform your GP that you are participating, if you give your consent to do so. What will happen to the results of the research study? We expect the results of the research will be submitted for publication in a medical journal in a few years time. A copy of the publication will be obtainable from the Drug Safety Research Unit (DSRU). You will not be identified in any publication, and no personal information will be used.
Who is organising and funding the research?
The study is to be carried out independently by the DSRU in Southampton, although it receives financial support from Bayer, the manufacturers of Xarelto®.
Who has reviewed the study?
The National Research Ethics Service South Central Hampshire A Research Ethics Committee has reviewed the study.
Independent information about taking part in health research is available from the Association of Research Ethics Committees at www.arec.org.uk
Thank you for considering participation in this study. If you agree you will be given a copy of the information sheet and a signed consent form to keep.