Status:
COMPLETED
Helicobacter Eradication Aspirin Trial
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Nottingham University Hospitals NHS Trust
University of Southampton
Conditions:
Gastrointestinal Ulcer Haemorrhage
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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...
Detailed Description
BACKGROUND: Aspirin use is widespread and increasing in elderly patients. The main hazard is gastrointestinal bleeding, the incidence of which is rising, probably because of increased aspirin use. The...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2022
Estimated Enrollment :
30024 Patients enrolled
Trial Details
Trial ID
NCT01506986
Start Date
March 1 2012
End Date
March 16 2022
Last Update
May 17 2022
Active Locations (6)
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1
Queen's University
Belfast, United Kingdom, BT9 7HR
2
University of Birmingham
Birmingham, United Kingdom, B15 2TT
3
Durham University
Durham, United Kingdom, TS17 6BH
4
University of Nottingham
Nottingham, United Kingdom, NG7 2UH