Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224679
Status:
TERMINATED
Last Update Posted:
2012-06-05
First Post:
2005-09-19
Brief Title:
APACC StudyProspective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence
Status:
TERMINATED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 mgday or aspirin as acetylsalicylate of lysine 300 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RAF 95176 | None | None | None |
| P951202 | None | None | None |