Evaluation of H. pylori infection in aspirin users - pilot study

ISRCTN	ISRCTN10740230
DOI	https://doi.org/10.1186/ISRCTN10740230
Protocol serial number	G0700648
Sponsor	University of Nottingham (UK)
Funder	Medical Research Council (UK)

Submission date: 07/01/2008
Registration date: 27/03/2008
Last edited: 27/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Chris Hawkey
Scientific

Wolfson Digestive Diseases Centre
University Hospital
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 8231033
Email	cj.hawkey@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Part 1: Interventional, non-randomised controlled study. Part 2: Observational database study.
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Helicobacter pylori Eradication vs Aspirin Toxicity pilot study
Study acronym	HEAT
Study objectives	Eradication of H. pylori in patients taking aspirin regularly will reduce the risk of ulcer bleeds. More details can be found at: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0700648&CaseId=9889
Ethics approval(s)	Nottingham 2 Research Ethics Committee, 21/09/2007
Health condition(s) or problem(s) studied	Ulcer bleeding
Intervention	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.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Clarithromycin, omeprazole, metronidazole
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	905
Key inclusion criteria	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.
Key exclusion criteria	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
Date of first enrolment	01/02/2008
Date of final enrolment	31/07/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Wolfson Digestive Diseases Centre

Nottingham
NG7 2UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/07/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes