EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan (ENgAGE-Taiwan)

Bayer

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Other: No drug; Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)

Study type: Observational

Funder types: Industry

Identifiers

NCT03579732

19882

Details and patient eligibility

About

The study evaluates the protective effect of low-dose aspirin use on gastrointestinal cancers (colorectal, esophageal and gastric cancers) in long-term users, episodic users and non-users of aspirin in Taiwan.

Full description

The primary objective is to investigate the protective effect of long-term low dose use of aspirin on colorectal, esophageal and gastric cancer in adult subjects from Taiwan.

Secondary objectives are to evaluate the protective effect by duration of low-dose aspirin use on colorectal cancer, the effect of discontinuation of aspirin on colorectal cancer prevention, the staging distribution of colorectal cancer and the description of fatal cases due to colorectal cancer.

Aspirin use will be identified through Taiwanese National Health Insurance (NIH) data from 2000 to 2015. Cancer cases and staging of the three cancer types will be ascertained through the Taiwan Cancer Registry, using data from 2000 to 2014. Fatal cases will be ascertained using Mortality database from 2000 to 2015.

Enrollment: 4,710,504 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40 or older at the cohort entry date.
• Taiwanese National Health Insurance enrollees with non-missing and consistent age and gender information.

Exclusion criteria

• Subjects with any cancer diagnosis before cohort entry date.
• No use of National Health Insurance before the cohort entry date.
• Low dose aspirin prescription before cohort entry date.
• Subjects with conditions contra-indicated for low dose aspirin use before cohort entry date.

Trial design

4,710,504 participants in 4 patient groups

Long-term users

Description:

Adults using low-dose aspirin for \> 3 years

Treatment:

Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)

Episodic users

Description:

Adults using low-dose aspirin inconsistently, or consistently but \< 3 years

Treatment:

Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)

Former users

Description:

Subset of adult Episodic users of aspirin who discontinued the drug for at least 1 year before case/ control date

Treatment:

Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)

Non-consumers

Description:

Adults who did not use low-dose aspirin

Treatment:

Other: No drug