After determining inclusion and exclusion criteria, individuals will be tested for H pylori (HP) infection by urease breath test (UBT). H pylori-positive subjects will undergo eradication by standard protocol. After successful treatment, subjects will be randomly allocated in two groups; ASA and placebo. After giving informed consent, participants will be followed up for 10 years. During these 10 years, participants will be regularly contacted every year to determine outcomes and complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105082032N3
Registration date:2017-04-21, 1396/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Farhad Pourfarzi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 9011
Email address
f.pourfarzi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
- Ministry of Health and Medical Education
- Ardabil University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Low-dose Aspirin in the Prevention of Gastric Cancer
Public title
The effect of Low-dose Aspirin in the Prevention of Gastric Cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:Negative pregnancy test ؛ Willing to participate in the study ؛ Willing to provide biological specimens ؛ Willing to discontinue alcohol consumption during study ؛ Willing to discontinue use of non-study PPIs and H2 blockers during study
Exclusion Criteria: Pregnancy ؛ History of peptic ulcer ؛ History of GI bleeding/ perforation ؛ Severe dyspepsia ؛ Known allergy to any of the study medications ؛ Known medical conditions (other than H. pylori) that preclude, or require, antibiotic therapy ؛ Known medical conditions that could limit life expectancy ؛ Prior esophageal or gastric malignancy or a gastrectomy
Age
From 35 years old to 69 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
28000
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Daneshgah St
City
Ardabil
Postal code
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.ARUMS.REC.1395.135
Health conditions studied
1
Description of health condition studied
Gastric Cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
Gastric Cancer
Timepoint
5 years following end of treatment
Method of measurement
Age standardized Incidence Rate
Secondary outcomes
empty
Intervention groups
1
Description
Tablet Aspirin 81 mg once daily (Trial group)
Category
Treatment - Drugs
2
Description
Placebo (Control)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Cohort Studies Center
Full name of responsible person
Dr. Farhad Pourfarzi
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ministry of Health and Medical Education
Full name of responsible person
Dr. Reza Malekzadeh
Street address
Ministry of Health and Medical Education
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ministry of Health and Medical Education
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Godrat Akhavan Akbari
Street address
Daneshgah St.
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Farhad Pourfarzi
Position
Principal Investigator/Associate Professor
Other areas of specialty/work
Street address
Ardabil
City
Ardabil
Postal code
Phone
+98 45 3325 9011
Fax
Email
f.pourfarzi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Farhad pourfarzi
Position
Principal Investigator / Associate Professor
Other areas of specialty/work
Street address
Ardabil
City
Ardabil
Postal code
Phone
+98 45 3325 9011
Fax
Email
f.pourfarzi@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Farhad Pourfarzi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)