Helicobacter Eradication Aspirin Trial

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nottingham
• Collaborators: Nottingham University Hospitals NHS Trust; Queen's University, Belfast; University of Birmingham; University of Durham; University of Oxford; University of Southampton
• Treatments: Aspirin; Clarithromycin; Dexlansoprazole; Lansoprazole; Metronidazole

Criteria

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-morbidity.

• Subjects whose behaviour or lifestyle would render them less likely to comply with study medication (eg. alcoholism, substance abuse, debilitating psychiatric conditions or inability to provide informed consent).

• Subjects currently participating in another interventional clinical trial or who have taken part in a trial in the previous three months.