Helicobacter Eradication Aspirin Trial (HEAT)
| ISRCTN | ISRCTN10134725 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10134725 |
| EudraCT/CTIS number | 2011-003425-96 |
| ClinicalTrials.gov number | NCT01506986 |
| Secondary identifying numbers | 11091 |
- Submission date
- 19/12/2011
- Registration date
- 28/12/2011
- Last edited
- 13/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Aspirin is a medicine that reduces the risk of clots forming in your blood. Aspirin use is widespread and increasing in elderly patients. The main side effect is gastrointestinal (digestive tract) bleeding, the incidence of which is rising, probably because of increased aspirin use. We think that the bacterium Helicobacter pylori causes stomach ulcers and aspirin, by thinning the blood, makes the ulcers bleed. If the bacterium is eradicated the patient will not get an ulcer and therefore there is no increased bleeding risk with aspirin. The aim of this study is to find out whether a one-week course of H. pylori eradication will reduce the rate of hospitalisation due to ulcer bleeding.
Who can participate?
Patients over 60 using aspirin daily who are infected with H. pylori.
What does the study involve?
Participants are randomly allocated to either treatment to eradicate H. pylori or placebo (dummy tablets). There will be no follow-up visits for 90% of patients. Instead we will use GP electronic databases to identify hospital admissions for ulcer bleeding. A random sample of participants will be breath tested at the end of the study to ensure that we are achieving similar H. pylori eradication rates to those achieved in our previous study.
What are the possible benefits and risks of participating?
A positive result would increase patient safety, reduce hospitalisations for gastrointestinal bleeding, reduce premature death, decrease medical costs and expand the number of patients for whom aspirin is beneficial.
Where is the study run from?
Nottingham Digestive Diseases Centre (UK)
When is the study starting and how long is it expected to run for?
March 2012 to December 2021 (updated 14/01/2021, previously: April 2017)
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)
Who is the main contact?
Jennifer Dumbleton
jennifer.dumbleton@nottingham.ac.uk
Contact information
Scientific
Nottingham Digestive Diseases Centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
Scientific
Nottingham Digestive Diseases Centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
 ORCID ID |
0000-0001-9099-5555 |
|---|
Study information
| Study design | Double-blind placebo-controlled randomised multi-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Helicobacter eradication to prevent ulcer bleeding in aspirin users: a large simple randomised controlled trial |
| Study acronym | HEAT |
| Study hypothesis | Current hypothesis as of 25/05/2016: A one week course of Helicobacter pylori (H. pylori) eradication in patients using aspirin (less than 325mg) daily will reduce the incidence of subsequent adjudicated peptic ulcer bleeding which results in hospitalisation. Previous hypothesis: A one week course of Helicobacter pylori (H. pylori) eradication in patients using aspirin (325mg) daily will reduce the incidence of subsequent adjudicated peptic ulcer bleeding which results in hospitalisation. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/095552 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/54555/PRO-09-55-52.pdf |
| Ethics approval(s) | East Midlands Research Ethics Committee, 08/12/2011, ref: 11/EM/0434 |
| Condition | Patients using aspirin less than 325mg daily |
| Intervention | Active treatment will consist of seven days of lansoprazole 30mg, clarithromycin 500mg and metronidazole 400mg all given twice daily. This is one of the authorised recommended regimens for H. pylori eradication in adults. The control group will receive placebos to the same regimen: Lansoprazole (CAS: 103577-45-3); 30mg capsules (generic) Clarithromycin (CAS: 81103-11-9); 500mg tablets (generic) Metronidazole (CAS: 99616-64-5); 400mg tablets (generic) Current interventions as of 25/05/2016: The trial will continue until 87 adjudicated events have occurred, which would occur after a mean 2.5 patient years of follow-up, if trial assumptions are correct. Previous interventions: The trial will continue until 96 adjudicated events have occurred, which would occur after a mean 2.5 patient years of follow-up, if trial assumptions are correct. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Clarithromycin, lansoprazole, metronidazole |
| Primary outcome measure | The rate of hospitalisation due to peptic ulcer bleeding in patients who enter the randomised study (only the first event per patient will be analysed), adjudicated by a blinded committee as definite or probable. The committee will use definitions validated in the TARGET study. |
| Secondary outcome measures | 1. Other causes of GI bleeding (adjudicated); these are predicted not to be affected by H. pylori eradication and will act as a specificity control 2. Cardiovascular outcomes (APTC endpoint, MI and stroke, unadjudicated); these are predicted not to be affected 3. The incidence of detected uncomplicated ulcers 4. Ulcer site (Duodenal Ulcer vs. Gastric Ulcer) 5. GP-recorded and patient-reported dyspepsia 6. Need for PPI prescription or other antiulcer/dyspepsia medication |
| Overall study start date | 01/03/2012 |
| Overall study end date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 33,000 |
| Participant inclusion criteria | 1. Males and females more than 60 years of age at the date of screening 2. Subjects who are taking aspirin less than 325mg daily and who have had 4 or more 28 day prescriptions in the last year 3. Subjects who are concurrently using other anti-platelet agents are allowed to enter the study 4. 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) 5. Subjects who are willing to give permission for their paper and electronic medical records to be accessed and abstracted by trial investigators 6. Subjects who are willing to be contacted and interviewed by trial investigators, should the need arise for adverse event assessment, etc 7. 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 |
| Participant exclusion criteria | 1. Subjects who are currently prescribed anti-ulcer therapy such as H2-receptor antagonists and proton-pump inhibitors 2. Subjects who are currently prescribed oral non-steroidal anti-inflammatory drugs (NSAIDs) 3. Subjects who have a known intolerance or allergy to H. pylori eradication treatment 4. Subjects who are taking drugs with a clinically significant interaction with H. pylori eradication treatment 5. Subjects who are terminally ill or suffer from a life-threatening co-morbidity 6. 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) 7. Subjects currently participating in another interventional clinical trial or who have taken part in a trial in the previous three months |
| Recruitment start date | 01/03/2012 |
| Recruitment end date | 01/04/2017 |
Locations
Countries of recruitment
- England
- Northern Ireland
- United Kingdom
Study participating centres
NG7 2UH
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
University/education
Research Innovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/07/2015 | Yes | No | |
| Results article | 05/11/2022 | 13/06/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/06/2023: Publication reference added.
14/01/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/01/2020 to 31/12/2021.
2. The intention to publish date was changed from 01/12/2017 to 31/07/2020
3. The plain English summary was updated to reflect these changes.
11/07/2018: The following changes have been made:
1. The trial end date has been changed from 01/10/2017 to 31/01/2020.
2. The intention to publish date has been changed from 01/12/17 to 31/07/2020.
01/09/2016: the following changes were made to the trial record:
1. The recruitment end date was changed from 01/10/2016 to 01/04/2017.
2. The overall trial end date was changed from 01/04/2017 to 01/10/2017
25/05/2016: the following changes were made to the trial record:
1. The overall trial end date was changed from 01/03/2016 to 01/04/2017.
2. The target number of participants was changed from 40,000 to 33,000.
