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 (PEACOCS)

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Colorectal Cancer; Bleeding
• Intervention / Treatment: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

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.

• Study Type: Observational
• Enrollment (Actual): 2000000

Contacts and Locations

Study Locations

• United Kingdom
  • Mimicked Population, United Kingdom
    • Mimicked Population

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; hypothetical UK populations of adults aged 50-59 take low-dose aspirin for primary prevention	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Low-dose acetylsalicylic acid, Aspirin (75-150 mg)
Cohort 2; hypothetical UK populations of adults aged 50-59 take low-dose aspirin for secondary prevention	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Low-dose acetylsalicylic acid, Aspirin (75-150 mg)
Cohort 3; hypothetical UK populations of adults aged 50-59 do not take low-dose aspirin for primary prevention
Cohort 4; hypothetical UK populations of adults aged 50-59 do not take low-dose aspirin for secondary prevention
Cohort 5; hypothetical UK populations of adults aged 60-69 take low-dose aspirin for primary prevention	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Low-dose acetylsalicylic acid, Aspirin (75-150 mg)
Cohort 6; hypothetical UK populations of adults aged 60-69 take low-dose aspirin for secondary prevention	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Low-dose acetylsalicylic acid, Aspirin (75-150 mg)
Cohort 7; hypothetical UK populations of adults aged 60-69 do not take low-dose aspirin for primary prevention
Cohort 8; hypothetical UK populations of adults aged 60-69 do not take low-dose aspirin for secondary prevention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer Healthcare products.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Cardiovascular Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 20751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No