Innovating clinical trials for atrial fibrillation patients: the DARe2THINK approach

Status: Ongoing

The DaRe2 approach (healthcare Data for pragmatic clinical Research in the NHS – primary 2 secondary) will test a new way of running trials which 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 research. As an example of this new system, DaRe2THINK will target patients with Atrial Fibrillation (AF). AF is a common heart rhythm condition that leads to a high chance of stroke, frequent hospital admissions, a higher risk of cognitive decline and dementia.

Blood thinning tablets (anticoagulants) greatly reduce the number of patients with AF that will suffer a stroke, but are usually only given to older patients or those with other health issues. This leaves patients younger than 65 years, and some patients aged 65-75 without treatment that could prevent these devastating complications. A new class of blood thinning tablets are now widely used in the NHS which are more convenient for patients to take, with a lower risk of bleeding than older treatments. Using these drugs in younger patients could provide benefit, but this needs to be tested in a clinical trial.

With the support of a Patient and Public Involvement Team and a national network of research nurses and GPs, the trial will include 3,000 patients from up to 600 GP surgeries across England. Each patient will either continue their current treatment or start an additional blood thinning tablet on a random basis. Patients will be followed up automatically within the NHS to look at the difference in those who suffer from strokes, blood clots, heart attacks, other problems with the blood vessels and dementia. Patients will self-report their memory, reaction times and quality of life using simple questionnaires through their mobile phone or the internet, without needing to revisit their doctor.

Project aims

The aim of this study is to find out whether these newer blood thinning tablets can prevent serious long-term complications if used earlier in patients with AF.

The combination of information from the community as well as hospitals across the NHS will allow us to see whether these blood thinning tablets should be prescribed more widely. DaRe2THINK will also allow us to develop and improve this new clinical trial system so that future research in the NHS will continue to benefit those patients most in need.