Clinical trial NCT03904732: 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
Official title: Predictive Modelling of the Effects of Regular Low-dose Aspirin on COlorectal Cancer, Cardiovascular Disease and Safety Outcomes in Europe: PEACOCS Model EU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Cardiovascular Disease
Bleeding
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-04-05
Enrollment: 2000000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Disease prediction model using hypothetical populations of adults aged 50-59 and 60-69 years at increased CVD (cardiovascular disease) risk, taking aspirin for CVD (primary or secondary) prevention.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of myocardial infarction and ischaemic stroke
timeFrame: Up to 20 years
measure: Number of death due to myocardial infarction or due to ischaemic stroke
timeFrame: Up to 20 years
measure: Number of colorectal cancer (CRC)
timeFrame: Up to 20 years
measure: Number of death due to CRC
timeFrame: Up to 20 years
measure: Number of severe gastrointestinal (GI) bleeding requiring hospitalization
timeFrame: Up to 20 years
measure: Number of intracranial hemorrhage (ICH)
timeFrame: Up to 20 years
measure: Number of symptomatic peptic ulcers requiring hospitalization
timeFrame: Up to 20 years
measure: Number of deaths due to any other cause
timeFrame: Up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mimicked Population
country: United Kingdom
facility: Mimicked Population
Study officials:
References: