Study to Develop a Prediction Model to Understand the Effect of Low-dose Aspirin on Cancer That Develops in the Colon and/or the Rectum, Diseases That Affects the Heart or Blood Vessels and Safety Outcomes in European Countries. The Study is Also Called PEACOS Model EU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-15

Study Completion Date

2020-01-31

Brief Summary

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In this study researchers want to learn more about the effect of low-dose Aspirin on cancer that develops in the colon (the longest part of the large intestine) and/or the rectum (the last several inches of the large intestine before the anus), diseases that affects the heart or blood vessels and safety outcomes. Study will focus on two groups of adults aged 50-59 and 60-69 years having an increased risk of heart and/or blood vessel disease who are taking either low-dose aspirin or no low-dose aspirin for heart and/or blood vessel disease prevention. The model will be based on information publicly available either on government organization websites or in scientific journals. Based on these data researchers will focus in a first step to build a model of 2 million adults (1 million for each age group) for the UK population and in a second step, the model will be modified for use with other European countries, to reflect the epidemiology and guidelines for aspirin use in these countries.

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Detailed Description

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Observational Study Model is selected as "Other" - Reason: Individual-level state transition model simulating the number of events of CRC, CVD, safety events and deaths in hypothetical cohorts of 1 million adults aged 50-59 years and 1 million adults aged 60-69 years followed for 20 years or till death, whichever comes first. The hypothetical cohorts are reflective of a population eligible for taking aspirin for primary or secondary CVD prevention.

Time Perspective is also selected as "Other"

\- Reason: Individual-level state transition model built mimicking the UK population using data published in scientific international peer-reviewed journals or published data from government agencies. In a second phase, the model results will be extrapolated to other EU countries, modifying the model parameters to reflect the other EU countries epidemiology.

Conditions

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Colorectal Cancer Cardiovascular Disease Bleeding

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Cohort 1

hypothetical UK populations of adults aged 50-59 take low-dose aspirin for primary prevention

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type DRUG

Low-dose acetylsalicylic acid, Aspirin (75-150 mg)

Cohort 2

hypothetical UK populations of adults aged 50-59 take low-dose aspirin for secondary prevention

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type DRUG

Low-dose acetylsalicylic acid, Aspirin (75-150 mg)

Cohort 3

hypothetical UK populations of adults aged 50-59 do not take low-dose aspirin for primary prevention

No interventions assigned to this group

Cohort 4

hypothetical UK populations of adults aged 50-59 do not take low-dose aspirin for secondary prevention

No interventions assigned to this group

Cohort 5

hypothetical UK populations of adults aged 60-69 take low-dose aspirin for primary prevention

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type DRUG

Low-dose acetylsalicylic acid, Aspirin (75-150 mg)

Cohort 6

hypothetical UK populations of adults aged 60-69 take low-dose aspirin for secondary prevention

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type DRUG

Low-dose acetylsalicylic acid, Aspirin (75-150 mg)

Cohort 7

hypothetical UK populations of adults aged 60-69 do not take low-dose aspirin for primary prevention

No interventions assigned to this group

Cohort 8

hypothetical UK populations of adults aged 60-69 do not take low-dose aspirin for secondary prevention

No interventions assigned to this group

Interventions

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Acetylsalicylic Acid (Aspirin, BAYE4465)

Low-dose acetylsalicylic acid, Aspirin (75-150 mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- European populations (UK and other European countries) of adults aged 50-59 and 60-69 years eligible for using aspirin for primary or secondary CVD prevention. Subjects are eligible when they have no contra-indications, and are at increased risk of CVD (primary prevention) or have suffered from a previous CVD event