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ISRCTN
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ISRCTN10740230
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ClinicalTrials.gov identifier
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Public title
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Evaluation of H. pylori infection in aspirin users - pilot study
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Scientific title
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Helicobacter pylori Eradication vs Aspirin Toxicity pilot study
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Acronym
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HEAT
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Serial number at source
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G0700648
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Study hypothesis
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Eradication of H. pylori in patients taking aspirin regularly will reduce the risk of ulcer bleeds.
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Ethics approval
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Nottingham 2 Research Ethics Committee, approved on 21 September 2007.
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Study design
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Part 1: Interventional, non-randomised controlled study. Part 2: Observational database study.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Ulcer bleeding
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Participants - inclusion criteria
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1. Male and female patients aged 45 years of age or older
2. Patients who have given written informed consent
3. Patients taking aspirin (less than or equal to 300 mg daily)
NB: Patients who have previously been tested for H. pylori and/or had previous eradication therapy will not be excluded.
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Participants - exclusion criteria
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1. Patients currently taking anti-ulcer therapy (H2-receptor antagonists i.e. cimetidine, famotidine, nizatidine or ranitidine and Proton Pump Inhibitors [PPIs] i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole or rabeprazole sodium)
2. Patients currently taking non-selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (aceclofenac, acemetacin, azapropazone, dexibuprofen, dexketoprofen, diclofenac sodium, diflunisal, fenbufen, fenoprofen, flurbiprofen, ibuprofen, indometacin, ketoprofen, mefenamic acid, meloxicam, nabumetone, naproxen, piroxicam, sulindac, tenoxicam, or tiaprofenic acid)
3. Patients who are terminally ill
4. Patients who are allergic to any of the eradication treatment drugs
5. Patients who are currently being treated with an antibacterial or have had antibacterial treatment within the last 4 weeks
6. Patients who have had treatment with a PPI (listed above) within the last 2 weeks.
7. Women who are pregnant or breast feeding
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Anticipated start date
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01/02/2008
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Anticipated end date
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31/07/2008
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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905
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Interventions
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This trial has two parts:
Part 1: Interventional study. This study will establish the H. pylori infection rates and success of eradication therapy.
GPs will screen their patient records for potential participants (Aged >45 and on <300 mg aspirin/day, excluding ulcer healing drugs and NSAIDs) and write to them to invite them to take part in the study. All participants will have a 13C Urea breath test (to establish their H. pylori status) and a blood sample taken (for future H. pylori serology testing). For participants who test negative for H. pylori, this will be the end of their involvement in the study. All patients who test positive for H. pylori (there will be no randomisation) will be given eradication therapy (Clarithromycin 500 mg twice a day [bd], omeprazole 20 mg bd and metronidazole 400 mg bd. Eradication treatment will last 7 days), and retested 6-8 weeks later to test eradication success.
Part 2: Observational study. This is a database study to assess aspirin use in the target population and rates of ulcer bleeds.
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Primary outcome measure(s)
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1. Rate of aspirin use (results of Part 2 Observational study)
2. Rate of ulcer bleeding in patients using aspirin (results of Part 2 Observational study)
3. Level of H. pylori infection and subsequent eradication rates in aspirin patients at 6-8 weeks after the eradication therapy
4. Level of interest from GPs and patients for a randomised study and their preferred enrolment site
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Contact name
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Prof
Chris
Hawkey
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Address
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Wolfson Digestive Diseases Centre
University Hospital
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Tel
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+44 (0)115 8231033
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Email
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cj.hawkey@nottingham.ac.uk
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Sponsor
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University of Nottingham (UK)
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Address
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Research Innovation Services
King's Meadow Campus
Lenton Lane
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City/town
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Nottingham
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Zip/Postcode
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NG7 2NR
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Country
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United Kingdom
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Tel
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+44 (0)115 9515679
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Email
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paul.cartledge@nottingham.ac.uk
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Date applied
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07/01/2008
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Last edited
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28/04/2008
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Date ISRCTN assigned
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27/03/2008
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