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Helicobacter eradication to prevent ulcer bleeding in aspirin users trial

To test the hypothesis that a one week course of Helicobacter pylori (H. pylori) eradication in patients using aspirin ≤325mg daily will reduce the incidence of subsequent adjudicated peptic ulcer bleeding that results in hospitalisation.

Background

The use of aspirin for cardiovascular prophylaxis (and potentially cancer prevention) is widespread and increasing. The main hazard is ulcer bleeding. This is usually associated with H. pylori infection. It is important to determine whether this can be reduced or prevented by H. pylori eradication. Given the scale of aspirin use, its continuing increase and its contribution to ulcer bleeding, how to deal with this problem is arguably the most important question with regard to current iatrogenic medicine. This research study has primarily three primary objectives

  • Medical: To test the hypothesis that a one week course of Helicobacter pylori (H. pylori) eradication in patients using aspirin ≤325mg daily will reduce the incidence of subsequent adjudicated peptic ulcer bleeding that results in hospitalisation.
  • Economic: To test the hypothesis that the intervention has a positive net monetary benefit.
  • Methodological: To establish a methodology for large simple outcomes studies using electronically extracted Primary Care follow-up data, to reduce costs to a level that enables outcomes studies of clinically important questions to be done without the need of  industry support.
Study Design: Double-blind, placebo-controlled randomised multi-centre study.
Sponsor University of Nottingham
Ethical Approval: EudraCT Number: 2011-003425-96
Chief Investigator: Professor Christopher Hawkey (University of Nottingham)
External Trial Manager: Jennifer Dumbleton (University of Nottingham)
Email: heat@phc.ox.ac.uk

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