Helicobacter Eradication Aspirin Trial (HEAT)

• Research type

  Research Study

• Full title

  Helicobacter eradication to prevent ulcer bleeding in aspirin users: a large simple randomised controlled trial

• IRAS ID

  46787

• Contact name

  Christopher Hawkey

• Sponsor organisation

  University of Nottingham

• Eudract number

  2011-003425-96

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Aspirin use is widespread and increasing in elderly patients. This has led to an accompanying rise in gastrointestinal bleeding, the principal hazard of long-term aspirin use. This trial is based on evidence that ulcer bleeding in aspirin users occurs predominantly in people infected with the bacterium H. pylori. Development of the trial protocol has been based on results of a preparatory MRC-funded 2525 patient pilot study. This enabled us to design a large simple outcomes trial to investigate directly the hypothesis that a one week course of H. pylori eradication treatment in patients using aspirin =325mg daily will reduce the incidence of subsequent adjudicated peptic ulcer bleeding that results in hospitalisation over a period of approximately 2-3 years. A large number of patients (~120,000) using aspirin =325mg daily will be invited to participate. Suitable respondents (~40,000) will be consented, given a brief health check, and breath tested, with those who are H. pylori positive (~10,000 based on the pilot study) being randomised to eradication treatment or placebo. There will be no follow-up trial visits. Instead MIQUEST (Morbidity Information Query and Export Syntax Tool), which was developed to interrogate GP electronic databases, will be used together with direct patient notification to identify all possible ulcer bleeding admissions. An expert panel will use validated methodology to adjudicate whether patients have suffered ulcer bleeding (primary endpoint). The trial will continue until 96 positively-adjudicated endpoints have occurred, to ensure it has the power to answer the question of whether H. pylori eradication reduces the risk of ulcer bleeding. This trial is important because it deals with the most significant pathology associated with aspirin, taken by 28% of the over 60s for cardiovascular protection. A positive result would increase patient safety, decrease medical costs, and expand the number of patients for whom aspirin has a net benefit.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0434

• Date of REC Opinion

  8 Dec 2011

• REC opinion

  Favourable Opinion