A five-year study aiming to reduce the risk of stomach bleeding in aspirin users, led by University of Nottingham researchers, is believed to be the UK’s largest interventional academic drug trial.
The HEAT study, which was led by Professor Chris Hawkey in the University’s School of Medicine and Nottingham Digestive Diseases Centre, and funded and supported by the National Institute for Health Research (NIHR), recruited more than 30,000 patients.
In low doses, aspirin is used as a long-term treatment to prevent heart attacks and strokes. Researchers on the study believe that by thinning the blood, aspirin makes ulcers in the stomach bleed. These ulcers may be caused by a particular type of bacteria, helicobacter pylori, and so the study aims to find out whether a short course of antibiotics to remove these bacteria will reduce the risk of bleeding in aspirin users.
If successful, the study will help to reduce NHS costs and improve health outcomes by reducing hospital admissions and increasing patient safety.
More than 1,260 general practices across the UK took part in this study to recruit the huge numbers of participants needed to answer this important research question.
Professor Hawkey, Chief Investigator of the study, explained: “Aspirin use is widespread, especially among the elderly, and there is increasing evidence that it may slow down certain cancers. However, a side effect of long-term use can include ulcer bleeding.
“We know interventional trials are influential, however if the outcome being investigated occurs infrequently, studies need to be conducted on a large scale.”
General practices issued more than 185,000 invitation letters to potential participants aged 60 and over who were daily aspirin users.
In addition to supporting the set-up of the study, the NIHR funded approximately 80 clinical research nurses to then recruit patients. Once consented to take part in the study, patients were invited to take a breath test to see whether they had the bacteria in their system.
Regionally, 3,427 participants were recruited across 118 sites around the East Midlands. For patients who tested positive to the presence of the bacteria, they were randomised to either receive an active form of the antibiotics, or a placebo treatment. Last year, there were almost 17,000 hospital admissions for gastric ulcers and more than 1,850 recorded deaths for gastric and duodenal ulcers.
Phil Evans, GP and NIHR National Specialty Lead for Primary Care, said: “The HEAT study is an excellent example of how you can deliver large scale research within the NHS. “This would not have been possible without the participation of general practices and patients, whose contribution to research is vital if we are to provide improved care and treatment in the future.”
In total, 5,357 patients tested positive for
H. pylori. These patients will continue to be followed up, with results of the study expected to be published in 2020.
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