drugset / Trial / NCT00224679
APACC Study:Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence
Phase 3
Terminated
300 enrolled
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France · collabSanofi-Synthelabo · collabSociété Nationale Française de Gastroentérologie · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Experimental and epidemiologic studies have suggested that aspirin intake reduces the risk for colorectal cancer. In the APACC study we randomly assigned 291 patients to daily Aspirin or Placebo for 4 years. However, the available data are not sufficient to serve as the basis for firm recommendations
Timeline
- Start
- 1997-03
- Primary completion
- —
- Completion
- 1999-03
Outcome
Missed primary endpoint
paper There was no difference in the proportion of patients with at least one recurrent adenoma between patients receiving aspirin at either dose and those treated with placebo (42/102 (41%) vs 33/83 (40%); NS) PMID 21890814 ↗
paper or in the adenomatous polyp burden (3.1 ± 5.8 mm vs 3.4 ± 6.2 mm; NS). PMID 21890814 ↗
Publications
- Background Benamouzig R, Deyra J, Martin A, Girard B, Jullian E, Piednoir B, Couturier D, Coste T, Little J, Chaussade S. Daily soluble aspirin and prevention of colorectal adenoma recurrence: one-year results of the APACC trial. Gastroenterology. 2003 Aug;125(2):328-36. doi: 10.1016/s0016-5085(03)00887-4.
- Benamouzig R, Uzzan B, Deyra J, Martin A, Girard B, Little J, Chaussade S; Association pour la Prevention par l'Aspirine du Cancer Colorectal Study Group (APACC). Prevention by daily soluble aspirin of colorectal adenoma recurrence: 4-year results of the APACC randomised trial. Gut. 2012 Feb;61(2):255-61. doi: 10.1136/gutjnl-2011-300113. Epub 2011 Sep 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 160 mg | — |
| Subject | Aspirin | Small molecule | 300 mg | — |