CompletedNot Applicable

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

United Kingdom2,000,000 participantsStarted 2019-04-15

Plain-language 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.

Who can participate

Age range

50 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of myocardial infarction and ischaemic stroke

Timeframe: Up to 20 years

Number of death due to myocardial infarction or due to ischaemic stroke

Timeframe: Up to 20 years

Number of colorectal cancer (CRC)

Timeframe: Up to 20 years

Number of death due to CRC

Timeframe: Up to 20 years

Number of severe gastrointestinal (GI) bleeding requiring hospitalization

Timeframe: Up to 20 years

Number of intracranial hemorrhage (ICH)

Timeframe: Up to 20 years

Number of symptomatic peptic ulcers requiring hospitalization

Timeframe: Up to 20 years

Trial details

NCT IDNCT03904732

SponsorBayer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-01-31

View on ClinicalTrials.gov More Colorectal Cancer trials

Plain-language summary

Who can participate

Age range

50 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of myocardial infarction and ischaemic stroke

Timeframe: Up to 20 years

Number of death due to myocardial infarction or due to ischaemic stroke

Timeframe: Up to 20 years

Number of colorectal cancer (CRC)

Timeframe: Up to 20 years

Number of death due to CRC

Timeframe: Up to 20 years

Number of severe gastrointestinal (GI) bleeding requiring hospitalization

Timeframe: Up to 20 years

Number of intracranial hemorrhage (ICH)

Timeframe: Up to 20 years

Number of symptomatic peptic ulcers requiring hospitalization

Timeframe: Up to 20 years