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Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence

Phase 3
18 Years
75 Years
Not Enrolling
Colon Adenomas

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Trial Information

Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence

The APACC Study is a prospected, randomized, double-blind, placebo-controlled multicentre
clinical trial design to test the efficacy of regular low-dose aspirin administration in
reducing the recurrence rate of colorectal adenomatous polyps. The study involved 49
gastroenterology centers from various parts of France. Patients were eligible if they had
either at least 3 adenomas irrespective of size, or at least one measuring 6mm in diameter
or more histologically confirmed colorectal adenomatous polyp by the local pathologist, and
2 independent pathologists, underwent a complete colonoscopy with polypectomy and were then
confirmed free of polyps, were aged between 18 and 75 years at recruitment, and were be able
to conform to the protocol during the study period. During a 4-week run-in period before
enrolment, all subjects took 300 mg aspirin per day to test tolerance and compliance with
the treatment. They were then randomized to either of the following three groups: placebo,
aspirin as acetylsalicylate of lysine 160 mg/day or aspirin as acetylsalicylate of lysine
300 mg/day. Information on compliance, tolerance of the treatment and concomitant disease is
obtained at regular clinical visits every 4 months. Informations on factors such as smocking
habits, previous medical history was recorded at enrollment. The primary outcomes were
defined as the proportion of subjects in whom at least one new adenoma was detected, and the
adenomatous polyp burden calculated as the sum of the diameters of these adenomas at the
follow-up colonoscopy 1 and 4 years after enrollment.

Inclusion Criteria:

- Patients are aged between 18 and 75 years At least 3 adenomas irrespective size or at
least one measuring 6mm or more All subjects had a clean colon at the study entry

Exclusion Criteria:

- No personal history of colon cancer, no inflammatory bowel disease, no familial
adenomatous polyposis, no regular use of aspirin

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Is daily soluble aspirin associated with a reduction in the risk for recurrent adenomas at 1 and 4 years after starting treatment.

Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:

AOM 95176



Start Date:

March 1997

Completion Date:

March 1999

Related Keywords:

  • Colon Adenomas
  • Colon cancer
  • Aspirin
  • Adenomas
  • Prevention
  • Adenoma
  • Recurrence