A clinical trial led by University of Nottingham in the U.K. will test the effect of removing a common stomach bacteria on making aspirin safer for some patients. The Helicobacter Eradication Aspirin Trial (HEAT) will also involve academics from Durham, Southampton, Oxford, and Birmingham universities.
The trial will investigate if removing the bacterium Helicobacter pylori (H. pylori) in the stomachs of patients taking up to 325 milligrams of aspirin a day could reduce their chances of developing a stomach ulcer and dangerous associated bleeding. The study is expected to enroll some 10,000 aspirin patients found to be infected with H. pylori.
Daily aspirin use is often recommended for people at risk of heart attack or stroke because its ability to lessen clotting in arteries. Blocked arteries prevent blood flow to the heart or brain and can cause a heart attack or stroke. Aspirin therapy reduces the clumping action of platelets, and thus can help prevent a heart attack or stroke.
Aspirin, however, is associated with stomach ulcers and bleeding in the stomach. Previous studies suggest that low dose aspirin is more likely to cause ulcer bleeding in patients infected with H. pylori. The researchers cite an endoscopy study that shows patients with the bug were five times more likely to develop a stomach ulcer than their H. pylori-free counterparts.
In the trial, patients infected with H. pylori (determined by a breath test) will either be given a course of medication aimed at eradicating the infection or a placebo, while continuing to take their aspirin. A research team will follow-up over two to three years to establish if the patient has developed a stomach ulcer after receiving the treatment. At the end of the trial, the team will compare the results to determine if those who received the medication developed fewer stomach ulcers and experienced gastric bleeding than those who received the placebo.
The patient follow-up will be done through interrogation of electronic health records rather than a separate clinical trial. The researchers plan to use the Morbidity Information Query and Export Syntax (MIQUEST) software developed at Nottingham that collects data from general medical practices in the U.K.
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