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Completed

NCT Number: 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

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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Key information

Conditions

Colorectal Cancer Bleeding Cardiovascular Disease Cardiovascular Diseases Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hemorrhage Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mimicked Population

Mimicked Population, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetylsalicylic acid (Aspirin, BAYE4465)

Drug

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

Primary outcomes

  1. Number of myocardial infarction and ischaemic stroke

    Time frame: Up to 20 years

    Calculated results using a mimicked population

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

    Time frame: Up to 20 years

    Calculated results using a mimicked population

  3. Number of colorectal cancer (CRC)

    Time frame: Up to 20 years

    Calculated results using a mimicked population

  4. Number of death due to CRC

    Time frame: Up to 20 years

    Calculated results using a mimicked population

  5. Number of severe gastrointestinal (GI) bleeding requiring hospitalization

    Time frame: Up to 20 years

    Calculated results using a mimicked population

  6. Number of intracranial hemorrhage (ICH)

    Time frame: Up to 20 years

    Calculated results using a mimicked population

  7. Number of symptomatic peptic ulcers requiring hospitalization

    Time frame: Up to 20 years

    Calculated results using a mimicked population

  8. Number of deaths due to any other cause

    Time frame: Up to 20 years

    Calculated results using a mimicked population

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: PEACOCS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2019
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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