AspECT
Esomeprazole and aspirin in Barrett's oesophagus (AspECT): a randomised factorial trial (Aspirin and Esomeprazole Chemoprevention in Barrett's metaplasia Trial)
Phase 3N = 2,557NCT00357682
- Population
- Patients with Barrett's oesophagus of 1 cm or more
- Design
- Unblinded 2 x 2 factorial randomised trial at 84 centres in the UK and one in Canada; reporting pathologists were masked. Patients were randomised 1:1:1:1 to high-dose (40 mg twice daily) or low-dose (20 mg once daily) esomeprazole, with or without aspirin (300 mg per day in the UK, 325 mg in Canada), for at least 8 years. 2557 patients recruited between March 2005 and March 2009. Primary analysis: accelerated failure time modelling, intention-to-treat. EudraCT 2004-003836-77; ClinicalTrials.gov NCT00357682 lists the same EudraCT number and 2557 actual enrolment.
- Primary endpoint
- Time to death, oesophageal adenocarcinoma or high-grade dysplasia
- Arms
- Low-dose PPI, no aspirin (control, n = 705): Esomeprazole 20 mg once daily, no aspirin
- High-dose PPI, no aspirin (experimental, n = 704): Esomeprazole 40 mg twice daily, no aspirin
- Low-dose PPI plus aspirin (experimental, n = 571): Esomeprazole 20 mg once daily plus aspirin 300 mg (UK) or 325 mg (Canada) daily
- High-dose PPI plus aspirin (experimental, n = 577): Esomeprazole 40 mg twice daily plus aspirin 300 mg (UK) or 325 mg (Canada) daily
- People
- Jankowski JAZ