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Trial record 4 of 6 for:    "Colorectal Adenoma" | "Fibrinolytic Agents"

APACC Study:Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence

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ClinicalTrials.gov Identifier: NCT00224679
Recruitment Status : Terminated
First Posted : September 23, 2005
Last Update Posted : June 5, 2012
Sponsor:
Collaborators:
Société Nationale Française de Gastroentérologie
Ministry of Health, France
Sanofi-Synthelabo
Information provided by:
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Colon Adenomas Drug: Aspirin Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence
Study Start Date : March 1997
Study Completion Date : March 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224679


Locations
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France
Hôpital COCHIN Service d'Hépato-Gastro-Entérologie
Paris, Ile de France, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Société Nationale Française de Gastroentérologie
Ministry of Health, France
Sanofi-Synthelabo
Investigators
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Principal Investigator: Stanislas CHAUSSADE, MD Assistance Publique - Hôpitaux de Paris

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00224679     History of Changes
Other Study ID Numbers: AOM 95176
P951202
RAF 95176
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: September 2006
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Colon cancer
Aspirin
Adenomas
Prevention
Additional relevant MeSH terms:
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Fibrinolytic Agents
Adenoma
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics