The effect of Low-dose Aspirin in the Prevention of Gastric Cancer

Evaluation of low-dose aspirin in the prevention of gastric cancer (GC)

Two arms parallel-group simple randomized clinical trial (phase 3,4) to assessment prevention of gastric cancer event. . The subjects (21000 persons) will first be tested for Helicobacter pylori using a stool antigen test. Affected people receive standard drug treatment. After being infected with Helicobacter pylori, they are randomly divided into two groups. The first group is given a daily aspirin tablet of 81 mg Parsdarou company and the control group is given a placebo prepared by the same factory. After signing the consent form, individuals will enter the study and will be followed up for 10 years.

Ardabil is an area with a high incidence of gastric cancer. In the University digestive disease research center, the group of people is randomly selected and invited using the city's household health record. After obtaining consent, individuals are evaluated for Helicobacter pylori and treated if necessary. They are then randomly divided into intervention and control groups and followed for ten years for gastric cancer. Participants and follow-up and statistics groups are blinded.

Inclusion Criteria: Without a history of gastric cancer Resident in Ardabil Age 35 - 70 Willing to undergo the treatments and procedures described in the protocol Willing to provide necessary biological specimens Willing to sign an informed consent form Exclusion Criteria: 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

Asprin and placebo group

Gastric cancer event

The new sample size (21000 participants) was calculated and applied according to the updated information and executive restrictions.

- Ministry of Health and Medical Education - Ardabil University of Medical Sciences

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

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.