Aspirin esomeprazole chemoprevention trial

Phase 3

Completed

• Conditions: Barrett's oesophagus due to chronic reflux in the gullet; Digestive System; Barrett's oesophagus

• Registration Number: ISRCTN85156844
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30057104

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-15
• Study Completion: 2018-10-31
• Last Update Posted: 8 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2513

Inclusion Criteria

Inclusion criteria as of 24/08/2016:
1. Patients aged over 18 years
2. Circumferential Barrett’s metaplasia of at least 1 cm in length (=C1M1) or a tongue of Barrett’s metaplasia of at least 2 cm in length (=C0M2) (irrespective of the presence now or historically of histologically proven intestinal metaplasia)
3. Patient?s able to give written consent
4. Patient?s with World Health Organization (WHO) activity profile of 0 or 1 i.e. fully active and self-caring

Inclusion criteria from 22/05/2007 to 24/08/2016:
1. Patients aged over 18 years
2. Patient with circumferential Barrett?s Metaplasia at least 1 cm long, and histologically proven intestinal metaplasia in at least one sample
3. Patient?s able to give written consent
4. Patient?s with World Health Organization (WHO) activity profile of 0 or 1 i.e. fully active and self-caring

Inclusion criteria provided at time of registration:
1. Male between 40 - 75 years
2. At least 2 cm from the gastro-oesophageal junction of circumferential BM (histologically proven by intestinal metaplasia in at least one sample)
3. Able to give written consent
4. World Health Organization (WHO) activity profile of 0 i.e. fully active and self-caring

Exclusion Criteria

Exclusion criteria as of 24/08/2016:
1. Patients with high grade dysplasia or carcinoma at enrolment
2. Medical conditions which would make completing endoscopies or completing the trial difficult, including:
2.1. Frequent transient ischaemic attacks (3 or more) or severe cerebral vascular accident in the previous 6 months (patients answering yes were eligible for the PPI-only (non-aspirin) arms of the trial)
2.2. Severe respiratory disease with arterial oxygen saturation of less than 90% at rest
2.3. Severe ischaemic heart disease (exercise tolerance less than 100 yards or life expectancy < 4 years) or myocardial infarction in the previous 3 months
2.4. Severe inflammatory bowel disease requiring at least one hospital admission of 5 days in the last year or bowels open > 6 times/day
3. Patients with absolute contraindications to PPIs, aspirin or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants.
4. Pregnant or lactating women will not undergo endoscopy and may be given dispensation to stop drug therapy for a year. This should be discussed with the Trial Office.

Exclusion criteria from 22/05/2007 to 24/08/2016:
1. Patients with high grade dysplasia or carcinoma at enrolment;
2. Patients with medical conditions which would make completing endoscopies or the trial difficult to complete including:
2.1. Previous transient ischaemic attacks or cerebral vascular disease
2.2. Severe respiratory disease
2.3. Severe ischaemic heart disease or myocardial infarction in the previous 6 months
2.4. Inflammatory bowel disease
3. Patients who are on continuous aspirin or non-steroidal anti-inflammatories or Cox-2 inhibitors (more than 3 courses/year)
4. Patient?s with absolute contraindications to PPIs, aspirin or their excipients such as allergies, ulcers, renal impairment or use of oral anticoagulants
5. Pregnant or lactating women

Exclusion criteria provided at time of registration:
1. High grade dysplasia or carcinoma at enrolment
2. Medical conditions which would make endoscopy or the trial difficult or failure to complete including transient ischaemic attacks or cerebral vascular disease, severe respiratory disease, severe ischaemic heart disease or recent myocardial infarction or inflammatory bowel disease
3. Patients who are on continuous aspirin or non-steroidal drugs (more than 3 courses/year)
4. Absolute contraindications (ulcers) or allergies to PPIs or aspirin such as renal impairment and oral anticoagulants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Primary outcome measures as of 24/08/2016:<br> A composite primary endpoint of all-cause mortality and conversion to adenocarcinoma and conversion to high grade dysplasia, assessed after all patients have completed at least 8 years of follow up<br><br> Primary outcome measures from 22/05/2007 to 24/08/2016:<br> The following will be assessed at 4 and 8 years and four yearly until the end of study:<br> 1. Conversion to adenocarcinoma of the oesophagus<br> 2. Conversion to high grade dysplasia<br> 3. Death by all causes<br>