CompletedPhase 4

Helicobacter Eradication Aspirin Trial

United Kingdom30,024 participantsStarted 2012-03

Plain-language summary

HEAT (Helicobacter Eradication Aspirin Trial) is a large simple double-blind placebo controlled outcomes study of Helicobacter pylori (H. pylori) eradication to prevent ulcer bleeding in aspirin users. It will be run by the University of Nottingham, with recruiting centres across the UK. This trial is funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) Programme. Aspirin use is widespread and increasing in elderly patients. The main hazard is gastrointestinal bleeding, which may be increasing because of increasing aspirin use. This trial is based on evidence that peptic ulcer bleeding in aspirin users occurs predominantly in H. pylori positive people. Patients will be identified by their GPs, then asked to attend an appointment with a Research Nurse to consent to the trial and take a H. pylori breath test. Those with a positive result will be randomised to receive a one week course of either eradication treatment or placebo. No follow-up visits are required, but instead information will be extracted from the patients' electronic medical record using the MiQuest search tool. The trial will continue until 87 adjudicated events (hospitalisation because of definite or probable peptic ulcer bleeding) have occurred, which would occur after a mean 2.5 patient years of follow-up, if trial assumptions are correct.

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and females ≥ 60 years of age at the date of screening. * Subjects who are taking aspirin ≤325mg daily and who have had 4 or more 28-day prescriptions in the last year. * Subjects who are concurrently using other anti-platelet agents are allowed to enter the study. * Subjects who are willing and able to undergo a breath test for H. pylori, including fasting for 6 hours, and whose result is unequivocally positive (results of breath test will be determined post-screening). * Subjects who are willing to give permission for their paper and electronic medical records to be accessed and abstracted by trial investigators. * Subjects who are willing to be contacted and interviewed by trial investigators, should the need arise for adverse event assessment, etc. * Subjects must be able to communicate well with the investigator or designee, to understand and comply with the requirements of the study and to understand and sign the written informed consent. Exclusion Criteria: * Subjects who are currently prescribed anti-ulcer therapy such as H2-receptor antagonists and proton-pump inhibitors. * Subjects who are currently prescribed oral non-steroidal anti-inflammatory drugs (NSAIDs). * Subjects who have a known intolerance or allergy to H. pylori eradication treatment. * Subjects who are taking drugs with a clinically significant interaction with H. pylori eradication treatment. * Subjects who are terminally ill or suffer from a life-threatening co-morbidit…

What they're measuring

The rate of hospitalisation due to peptic ulcer bleeding in patients who enter the randomised study (only the first event per patient will be analysed), adjudicated by a blinded Committee as definite or probable.

Timeframe: 4 years

Trial details

NCT IDNCT01506986

SponsorUniversity of Nottingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10-31