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

Colorectal Cancer Clinical Trial

— PEACOCS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03904732
• Other study ID #: 20751
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: January 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000000
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Cardiovascular Disease
• Cardiovascular Diseases
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Acetylsalicylic Acid (Aspirin, BAYE4465)
Low-dose acetylsalicylic acid, Aspirin (75-150 mg)

Locations

Country	Name	City	State
United Kingdom	Mimicked Population	Mimicked Population

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

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

External Links

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