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IRCT201105082032N3 IRCT 2017-04-21 Ministry of Health and Medical Education The effect of Low-dose Aspirin in the Prevention of Gastric Cancer TELAPGC The effect of Low-dose Aspirin in the Prevention of Gastric Cancer 2017-04-21 anticipated 21000 Complete https://irct.ir/trial/1659 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible participants were randomly assigned to either aspirin or placebo groups with a 1:1 allocation ratio using permuted block randomization. Randomization was stratified by the initial HP status of subjects, baseline presence of intestinal metaplasia, and presence of two or more GC risk factors, to ensure recruitment balance between the two arms of the study. The permuted block sequence was generated with a block size of four. T, Blinding description: The provided medications, including aspirin and placebo, are small-sized white tablets. Aspirin and placebo bottles are both completely the same and labeled as “Artamed”. Both bottles contain 120 tablets, and the manufacturer prints a code on each bottle which can be used to determine the type of medication inside them. The codes were concealed in sealed and opaque envelopes with printed corresponding randomization numbers on them and kept safely in the study site with the personal investigator. DDRI provides and relabels the study drug and placebo to maintain the masking of the contents. The trial participants and care providers are blinded to the allocation. Staff independent of the study conduction enter data in the database using participants’ randomization codes so that outcome assessors and data analysts remain unaware of the treatment groups. 3 Gastric Cancer. Intervention 1: Tablet Aspirin 81 mg (oral) Parsdarou company once daily. Intervention 2: Placebo (Control):Tablet placebo (oral) Parsdarou company once daily. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no decision has been made for individual data publication by scientific committee
public Dr. Farhad Pourfarzi
Daneshgah St.
Ardabil Iran (Islamic Republic of) 5618985991 +98 45 3325 9011 f.pourfarzi@arums.ac.ir Ardabil University of Medical Sciences scientific Dr. Farhad pourfarzi
Daneshgah St
اردبیل Iran (Islamic Republic of) 5618985991 +98 45 3325 9011 farhad.pourfarzi@gmail.com Ardabil University of Medical Sciences Iran (Islamic Republic of) Living in the province for ten years Negative pregnancy test Willing to participate in the study Willing to provide biological specimens Willing to sign an informed consent form 35 years 70 years Both No history of Gastric cancer History of Severe dyspepsia, peptic ulcer and GI bleeding/ perforation History of NSAID gastritis Known allergy to any of the study medications Known medical conditions that could limit life expectancy (eg. HIV/AIDS, congestive heart failure, renal failure, hepatic failure, current or prior malignancy, any other chronic disease that limits function) Prior esophageal malignancy, gastric ulcer or a gastrectomy (full or partial) C16 Malignant neoplasm of stomach Treatment - Drugs Placebo Tablet Aspirin 81 mg (oral) Parsdarou company once daily Placebo (Control):Tablet placebo (oral) Parsdarou company once daily Gastric Cancer. Timepoint: visits at first, 12 weeks, every 4 months, 5 years and 10 years. Method of measurement: Age standardized Incidence and Mortality Rate. Ardabil University of Medical Sciences National Institute for Medical Research Development Ministry of Health and Medical Education Ardabil University of Medical Sciences National Institute for Medical Research Development Approved 2017-03-05 Ardabil University of Medical Sciences Daneshgah St Ardabil Ardabil Iran (Islamic Republic of)