Helicobacter Eradication Aspirin Trial

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.

Conditions

• Gastrointestinal Ulcer Haemorrhage
• Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Interventions

DRUG

Lansoprazole 30mg, Clarithromycin 500mg, Metronidazole 400mg

All three medications will be taken orally, twice daily, for seven days.

DRUG

Placebo lansoprazole 30mg, clarithromycin 500mg, metronidazole 400mg

Medication to be taken orally, twice a day, for seven days.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust

  collaborator OTHER

• University of Southampton

  collaborator OTHER

• University of Durham

  collaborator OTHER

• University of Birmingham

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• Queen's University, Belfast

  collaborator OTHER

• University of Nottingham

  lead OTHER

Principal Investigators

• Chris J Hawkey · University of Nottingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2017-10-31

Completion

2022-03-16

Countries

• United Kingdom

Study Locations