EffectiveNess of Low-dose Aspirin in Prevention of Cancer in the Stomach and Oesophagus (GastrointEstinal Cancer Prevention) - United Kingdom ("ENgAGE - UK"): Study to Evaluate the Risk of Cancer in the Stomach and Oesophagus Among New Users of Low-dose Aspirin Using the THIN Database in the UK (ENgAGE-UK)

Bayer

Status: Completed

Conditions: Prevention of Oesophagus Cancer and Stomach Cancer

Treatments: Drug: Acetylsalicylic Acid(BAYE4465, Aspirin )

Study type: Observational

Funder types: Industry

Identifiers

NCT03743883

20326

Details and patient eligibility

About

Researchers already did studies in low-dose Aspirin for the prevention of heart and blood vessels disease and for the prevention of cancer of the colorectum. In this study, they want to learn whether an effect for the prevention of oesophagus cancer and stomach cancer goes along with the use of low-dose ASA on patients taking this medicine for the prevention of heart and blood vessels disease compared to non-use. To find this out electronic medical records stored in primary care database in the UK, The Health Improvement Network (THIN), will be used.

Enrollment: 99,999 patients

Sex: All

Ages: 40 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 40-89 years
• Enrolled with the PCP for at least 2 years
• To have a history of computerized prescriptions in THIN for at least 1 year prior to start date

Exclusion criteria

• To be exposed to low-dose ASA before entering in the study
• Having a diagnosis of any cancer before entering in the study

Trial design

99,999 participants in 2 patient groups

Low-dose ASA cohort

Description:

A person is identified as newly exposed to low-dose ASA, he/she will become member of new user low-dose ASA cohort and that date will be the start date for outcome follow-up.

Treatment:

Drug: Acetylsalicylic Acid(BAYE4465, Aspirin )

Comparison unexposed cohort

Description:

When a member of new user low-dose ASA cohort is confirmed, one comparison member will be confirmed also from the source population not yet censored on that day (start date) and with the same distribution of matching factors (age, sex, time interval since entry date and number of PCP visits in the year prior to start date) of its low-dose ASA pair with the only difference of being free of ASA on start date.