For patients and the public

You have been invited by your GP as your medical record suggests you may be eligible for the trial.  It is up to you to decide whether to join the study or not. If you decide not to take part, your NHS care will not be affected. If you agree to take part, your GP will ask you to complete a consent form (through the internet or on paper). This will stay in your study file, be noted in your medical records and available for review by the study monitors, with a copy for you to keep. 

If you take part, your GP will confirm you are eligible to join the trial and then a computer will decide at random (like tossing a coin) which group you are assigned to:  

Group 1: You continue with your current treatment and will start a blood thinning tablet at age 75, or sooner if you have other medical conditions that lead to a high risk of stroke.

Group 2: In addition to any usual treatments, your GP will prescribe a blood thinning tablet called a DOAC (direct oral anticoagulant), with the precise drug you start depending on local NHS policies.  In some cases, your GP may stop prescribing drugs you are already taking, such as aspirin.

Once the treatment is assigned, you and your doctor will know which group you are in. In both groups, patients will be followed up automatically to check for strokes, blood clots, heart disease, bleeding episodes and dementia. We will do this by securely linking your NHS medical records (from your GP and hospital records) and medical information stored centrally by NHS Digital and the Office for National Statistics. 

Using this new system for NHS trials, you will not need to make any additional visits because of the trial. Information on your health status will come from your NHS medical records automatically.  You will be asked to report your quality of life every 6 months, and memory and reaction tests every 12 months during the 5 years of the study. A further check will be made after 10 years. These tests take about 10 minutes and will be texted to your mobile phone and sent to your email address. You can complete these on your phone or any device connected to the internet. If you don’t have a device that connects to the internet, you can use a friend or family member’s device, or use a public computer (for example at a library). However, you must complete the questions yourself. You will be sent reminders by text message and email to complete these tests at the right time.

We already know that AF can lead to strokes and dementia. The risk of these problems increases as you get older. Blood thinners are currently used in the NHS to prevent strokes in older patients.  They could also be valuable in younger patients, but we need to test that this is the case.  Your contribution is vital to helping future patients with AF receive the best treatment throughout the NHS and across the world.

Your contribution is vital to helping future patients with AF receive the best treatment throughout the NHS and across the world. 

Blood thinning drugs do not cause bleeding, but if bleeding is caused by another factor, they can make the bleeding worse. The newer blood thinners (DOACs) are much safer than older treatments such as warfarin and are now the standard of care within the NHS. Apart from AF, doctors commonly use these drugs to treat blood clots in the leg or lung, and certain types of heart and blood diseases. 

If you start a blood thinner, you will need to take extra care in day-to-day activities (for example, making sure you don’t fall or cut yourself shaving). Minor bleeding occurs in around 1 in 10 patients, but isn’t usually a reason to stop treatment and can be prevented by placing pressure on cuts or holding down longer after blood tests. They are established drugs, and your GP is used to prescribing and monitoring their use. Major bleeding usually only happens when there is an unknown health condition like a stomach ulcer. If you hit your head or collapse on blood thinners, you should seek medical attention.

This study will test a new way of running trials based at GP surgeries using routine NHS information. We aim to include patients that don’t normally take part in clinical trials and follow them up without the need to revisit their GP or attend hospital. This approach could improve the health and well-being of those treated by the NHS, whilst reducing the time needed from staff and patients to engage in important research. We are also testing if these blood thinners can save money for the NHS in the long term.

You will not receive any payment for taking part in this study. However, if you are below 60 years and randomised to the DOAC arm of the trial, we will issue electronic voucher payments every 6 months to compensate for your prescription costs. These vouchers can be used on various retail and entertainment websites all over the UK.

We plan to include 3000 patients with AF in this study. This includes patients from GP surgeries right across England.  

In order to find out which way of treating patients with AF is best, we need a clinical trial to compare starting blood thinners earlier than usual. Grouping patients in a random way ensures the information we get on these drugs is impartial, and can be used to help you and future patients with AF in the NHS.

Your GP will prescribe your medication in the normal way, which you can pick up or get delivered from your local pharmacy as usual. You should take the study medication regularly as directed, and continue all of your other medications as advised by your GP. Although there are no blood tests needed specifically for the study, most GPs will do blood tests every 6 months for patients on blood thinners. 

The treatments we are using have been prescribed for many years as part of the normal treatment for patients with AF. The tests are simple questions about your quality of life every 6 months, and reaction tests to look at cognitive function every 12 months. The results of the tests will not be available to you or your GP, and will not be used to plan your NHS care – so you should still report any health problems to your GP as usual, or seek advice from NHS 111. 

After the study finishes, your GP or any hospital teams you see will decide on your future treatment.  The treatments you have started may continue, or you may change to other treatments if these prove to be better.  If we find that starting blood thinners earlier is better, then this may become standard practice in the NHS.

Sometimes we get new information about the treatments being studied. If this happens, your GP will tell you and discuss whether you should continue in the study. If the study is stopped for any other reason, we will tell you and your GP will arrange your continuing care.

You should ask to speak to your GP if you encounter any problems. If you have a concern about any aspect of this study, you can also speak to the researchers (see contact details on the last page). In the event that something goes wrong and you are harmed during the research due to someone’s negligence, then you may have grounds for legal action. The normal NHS complaints mechanisms will also be available to you.

We are working with the Clinical Practice Research Datalink (CPRD), part of the UK Department of Health and Social Care. CPRD works with around 1 in 5 GPs across the UK to improve how health data collected as part of normal GP care can be used to benefit all patients. The secure system does not collect any identifying information, but can link to NHS hospital records and information from the Office for National Statistics. We will use this system so that you and your GP do not have to spend time completing lengthy study forms. When you join the study, we will ask for your consent to use this system periodically throughout your life to look for health issues related to this study.  With your consent, the research team will record your NHS number so we can obtain information about any stays in hospital. By joining the study, this supersedes any data opt-out you may have completed, but only for the purposes of this study.

You can withdraw from the study at any time without giving a reason and this will not affect any other treatment you are receiving. However, if you do withdraw, then your GP may stop any blood thinning medication started within the trial.   If you change your GP, you may also be withdrawn.   

The information collected from your medical records up to the point of your withdrawal can still be used.  You are able to opt out of the following future study activities by contacting the study coordinator:  

1) No longer receive any further health questionnaires. 

2) Cancel future access to your health records.  

3) Completely withdraw from all future aspects of the trial. 

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by the Ethics Committee. In addition, two independent groups of experts will help to ensure the trial is run correctly, and to ensure the safety of all study participants. 

All information which is collected about you, including from your medical records, will be kept strictly confidential, and any stored information about you will have your name and address removed so that you cannot be recognised. We will take all reasonable steps available in order to protect your privacy. Personal and research data will be stored for up to 25 years.  Any future use of this data will follow the same principles as discussed above, and only shared within the research team.  Outside of this team (including in any articles we publish about the research), all information will refer to groups of patients without any identifying details.

There may be additional studies either as part of this trial or others where your contribution could be helpful. When you are enrolled in the study you will be asked for your consent to contact you about future research. You can refuse without any consequence to this study or your NHS care.

At the end of the study, we plan to publish the study findings in a medical journal. You will not be identified in any publication. We will send a summary of the findings to your mobile phone and email address once the study has been published.

The study is sponsored by the University of Birmingham and is funded by the National Institute for Health Research (NIHR; part of the UK Department of Health and Social Care). Other members of the research team are CPRD, University Hospitals Birmingham NHS Foundation Trust, the University of Oxford and London School of Economics. No member of the research team is being paid for including you in this study.

• Only patients from participating GP surgeries can join the trial.
• If your GP surgery is part of the trial, and you meet the trial criteria, then you may be invited to join the trial. You will be provided with the patient information leaflet and will discuss whether it is right for you to join the trial with a staff member at your GP surgery.

You will be able to take part in DaRe2THINK if you:

1.     Have been diagnosed with AF.

2.     Are aged between 55 and 73

 And do not meet any of the following criteria:

1.      Currently taking any blood thinning medication.

2.      Have a clinical indication for anticoagulation.

3.      Any active clinically-significant bleeding.

4.      Have a life expectancy of less than 2 years.  

5.      Are unwilling to provide informed consent for access and linkage of electronic healthcare records.

6.      Currently participating in another clinical trial.

7.      Are a woman of childbearing potential.

(This is an example and not a complete list; your GP will assess your medical record for the full list of exclusion criteria). 

The privacy of your data is extremely important to us. 

• For information on how the University of Birmingham use/protect your data
• For information on how CPRD use/protect your data
• For information on how University Hospitals Birmingham use/protect your data