check_circleStudy Completed

Colorectal Cancer, Cardiovascular Disease, Bleeding

Bayer Identifier:

20751

ClinicalTrials.gov Identifier:

NCT03904732

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

50 - 69 Years
  • - 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
  • - None

Trial summary

Enrollment Goal
2000000
Trial Dates
April 2019 - January 2020
Phase
N/A
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Mimicked PopulationMimicked Population, United Kingdom

Primary Outcome

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

Trial design

Predictive modelling of the Effects of regular low-dose Aspirin on COlorectal cancer, Cardiovascular disease and Safety outcomes in Europe: PEACOCS model EU
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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