How many patients are involved?
From our pilot study we expect 40,000 patients to respond (from 120,000 invited) and that 10,000 will be H. pylori positive; 5000 of these will be randomised to eradication treatment and 5000 to matching placebo.
Who can enter?
- 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 currently taking anti-ulcer therapy such as H2-receptor antagonists and proton-pump inhibitors.
- Subjects who are currently taking 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.
- Protocol [.pdf 576KB]