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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Is daily soluble aspirin associated with a reduction in the risk for recurrent adenomas at 1 and 4 years after starting treatment.
Stanislas CHAUSSADE, MD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health
AOM 95176
NCT00224679
March 1997
March 1999
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