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17 May 2012
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| [ Print-friendly version ] |
| Helicobacter Eradication Aspirin Trial (HEAT) |
| ISRCTN | ISRCTN10134725 |
| ClinicalTrials.gov identifier | |
| Public title | Helicobacter Eradication Aspirin Trial (HEAT) |
| Scientific title | Helicobacter eradication to prevent ulcer bleeding in aspirin users: a large simple randomised controlled trial |
| Acronym | HEAT |
| Serial number at source | 11091 |
| Study 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. |
| Lay summary | Lay summary under review |
| Ethics approval |
East Midlands Research Ethics Committee, 8 December 2011, ref: 11/EM/0434
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| Study design | Double-blind placebo-controlled randomised multi-centre study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Patients using aspirin 325mg daily |
| Participants - 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 |
| Participants - exclusion criteria |
1. Subjects who are currently taking anti-ulcer therapy such as H2-receptor antagonists and proton-pump inhibitors
2. Subjects who are currently taking 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 |
| Anticipated start date | 01/03/2012 |
| Anticipated end date | 01/03/2016 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 40,000 |
| Interventions |
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 identical 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) 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. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) ref: 09/55/52 |
| Trial website | |
| Publications | |
| Contact name | Prof Chris Hawkey |
| Address |
Nottingham Digestive Diseases Centre
University Hospital |
| City/town | Nottingham |
| Zip/Postcode | NG7 2UH |
| Country | United Kingdom |
| Sponsor | University of Nottingham (UK) |
| Address |
Research Innovation Services
King’s Meadow Campus Lenton Lane |
| City/town | Nottingham |
| Zip/Postcode | NG7 2NR |
| Country | United Kingdom |
| Sponsor website: | http://www.nottingham.ac.uk/ |
| Date applied | 19/12/2011 |
| Last edited | 28/12/2011 |
| Date ISRCTN assigned | 28/12/2011 |
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