Effectiveness of Low Dose Aspirin in Decreasing the Chance Getting Stomach and Intestine Cancer

Completed

• Conditions: Gastrointestinal Cancer
• Interventions: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

• Registration Number: NCT04081831
• Lead Sponsor: Bayer

Brief Summary

In this study, researchers wanted to learn more about the effect of Aspirin taken as low dose (75 - 300 mg) in preventing stomach, colorectal and esophagus cancer. The researchers were interested in the effect by duration of aspirin use and the effect on the time since aspirin intake has been stopped in preventing stomach, colorectal and esophagus cancer. In addition, the study also looked into the time patients survived after being diagnosed (survival rate) with cancer and number of cancer patients who died (case fatality rate). The study was based on an electronic database managed by the Health Authority in Hong Kong containing anonymized clinical information of patients living in Hong Kong.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-30
• Study Start: 2019-07-31
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Primary Completion: 2020-08-25
• Study Completion: 2020-08-25
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99999

Inclusion Criteria

• Received prescription of either low-dose aspirin (75-300 mg) or paracetamol monotherapy during enrolment period.

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Exclusion Criteria

• Received prescription of aspirin monotherapy or combination one year prior to the index date
• Recorded diagnoses of any type of cancer before the index date
• Recorded procedures of colectomy, gastrectomy prior to the index date
• Age < 40 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
New-users of Low-dose aspirin (exposed group)	Acetylsalicylic Acid (Aspirin, BAYE4465)	New-users of low-dose aspirin is defined as patients who did not receive any prescriptions of low-dose aspirin one year prior to the index date.

Primary Outcome Measures

Name	Time	Method
Incidence rate ratio of colorectal cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)	Retrospective analysis between 1st January 2004 and 31st December 2008	Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Incidence rate ratio of gastric cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)	Retrospective analysis between 1st January 2004 and 31st December 2008	Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Incidence rate ratio of esophageal cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)	Retrospective analysis between 1st January 2004 and 31st December 2008	Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)

Secondary Outcome Measures

Name	Time	Method
Duration of aspirin use	Retrospective analysis between 1st January 2004 and 31st December 2008	Minimum duration of aspirin use to confer the protective effects in preventing colorectal, gastric and esophageal cancer
Risk of colorectal, gastric and esophageal cancer after discontinuation of aspirin use	Retrospective analysis between 1st January 2004 and 31st December 2008	Logistic regression will be conducted based on nested case-control study with stratification on the recency of exposure with current use, past use, and distant use of aspirin.
Case-fatality and survival rate	Retrospective analysis between 1st January 2004 and 31st December 2008	For colorectal cancer, gastric or oesophageal

Trial Locations

Locations (1)

University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong