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 Overview
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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.

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.

Official Title
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Predictive Modelling of the Effects of Regular Low-dose Aspirin on COlorectal Cancer, Cardiovascular Disease and Safety Outcomes in Europe: PEACOCS Model EU

Conditions
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Colorectal Cancer, Cardiovascular Disease, Bleeding

Intervention / Treatment
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* Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)


Participation Criteria
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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 Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>hypothetical UK populations of adults aged 50-59 take low-dose aspirin for primary prevention | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)<br>* Low-dose acetylsalicylic acid, Aspirin (75-150 mg)<br>|
| Cohort 2<br>hypothetical UK populations of adults aged 50-59 take low-dose aspirin for secondary prevention | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)<br>* Low-dose acetylsalicylic acid, Aspirin (75-150 mg)<br>|
| Cohort 3<br>hypothetical UK populations of adults aged 50-59 do not take low-dose aspirin for primary prevention | |
| Cohort 4<br>hypothetical UK populations of adults aged 50-59 do not take low-dose aspirin for secondary prevention | |
| Cohort 5<br>hypothetical UK populations of adults aged 60-69 take low-dose aspirin for primary prevention | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)<br>* Low-dose acetylsalicylic acid, Aspirin (75-150 mg)<br>|
| Cohort 6<br>hypothetical UK populations of adults aged 60-69 take low-dose aspirin for secondary prevention | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)<br>* Low-dose acetylsalicylic acid, Aspirin (75-150 mg)<br>|
| Cohort 7<br>hypothetical UK populations of adults aged 60-69 do not take low-dose aspirin for primary prevention | |
| Cohort 8<br>hypothetical UK populations of adults aged 60-69 do not take low-dose aspirin for secondary prevention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of myocardial infarction and ischaemic stroke | Calculated results using a mimicked population | Up to 20 years | 
| Number of death due to myocardial infarction or due to ischaemic stroke | Calculated results using a mimicked population | Up to 20 years | 
| Number of colorectal cancer (CRC) | Calculated results using a mimicked population | Up to 20 years | 
| Number of death due to CRC | Calculated results using a mimicked population | Up to 20 years | 
| Number of severe gastrointestinal (GI) bleeding requiring hospitalization | Calculated results using a mimicked population | Up to 20 years | 
| Number of intracranial hemorrhage (ICH) | Calculated results using a mimicked population | Up to 20 years | 
| Number of symptomatic peptic ulcers requiring hospitalization | Calculated results using a mimicked population | Up to 20 years | 
| Number of deaths due to any other cause | Calculated results using a mimicked population | Up to 20 years |