Colorectal CancerPEACOCSNCT03904732
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
An observational study of Colorectal Cancer and Cardiovascular Disease, run by Bayer at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Colorectal Cancer, Cardiovascular Disease, Bleeding
- What is being tested?
- Acetylsalicylic Acid (Aspirin, BAYE4465)
- How many people
- 2,000,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2019to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer, Cardiovascular Disease, Bleeding
- Being tested
- Acetylsalicylic Acid (Aspirin, BAYE4465)
- Medical subject headings
- Colorectal Neoplasms, Cardiovascular Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic Acid (Aspirin, BAYE4465)Drug
Low-dose acetylsalicylic acid, Aspirin (75-150 mg)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | hypothetical UK populations of adults aged 50-59 take low-dose aspirin for primary prevention Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) | |
| Cohort 2 | hypothetical UK populations of adults aged 50-59 take low-dose aspirin for secondary prevention Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) | |
| 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 Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) | |
| Cohort 6 | hypothetical UK populations of adults aged 60-69 take low-dose aspirin for secondary prevention Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of myocardial infarction and ischaemic stroke
Calculated results using a mimicked population
Measured: Up to 20 years
Number of death due to myocardial infarction or due to ischaemic stroke
Calculated results using a mimicked population
Measured: Up to 20 years
Number of colorectal cancer (CRC)
Calculated results using a mimicked population
Measured: Up to 20 years
Number of death due to CRC
Calculated results using a mimicked population
Measured: Up to 20 years
Number of severe gastrointestinal (GI) bleeding requiring hospitalization
Calculated results using a mimicked population
Measured: Up to 20 years
Number of intracranial hemorrhage (ICH)
Calculated results using a mimicked population
Measured: Up to 20 years
Number of symptomatic peptic ulcers requiring hospitalization
Calculated results using a mimicked population
Measured: Up to 20 years
Number of deaths due to any other cause
Calculated results using a mimicked population
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start15 Apr 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 2,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904732
- Sponsor's protocol ID
- 20751
- Acronym
- PEACOCS
- Status last verified
- Jan 2021
- First submitted
- 4 Apr 2019
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03904732
- Acronym / sponsor ID
- PEACOCS / 20751
- Conditions
- Colorectal Cancer, Cardiovascular Disease, Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)hypothetical UK populations of adults aged 50-59 take low-dose aspirin for primary prevention |
| Cohort 2 | – | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)hypothetical UK populations of adults aged 50-59 take low-dose aspirin for secondary prevention |
| 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 | – | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)hypothetical UK populations of adults aged 60-69 take low-dose aspirin for primary prevention |
| Cohort 6 | – | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)hypothetical UK populations of adults aged 60-69 take low-dose aspirin for secondary prevention |
| 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 |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic Acid (Aspirin, BAYE4465)Low-dose acetylsalicylic acid, Aspirin (75-150 mg) | Drug | Cohort 1, Cohort 2, Cohort 5, Cohort 6 |
Primary outcome
Number of myocardial infarction and ischaemic stroke
Time frame: Up to 20 years
Calculated results using a mimicked population
Number of death due to myocardial infarction or due to ischaemic stroke
Time frame: Up to 20 years
Calculated results using a mimicked population
Number of colorectal cancer (CRC)
Time frame: Up to 20 years
Calculated results using a mimicked population
Number of death due to CRC
Time frame: Up to 20 years
Calculated results using a mimicked population
Number of severe gastrointestinal (GI) bleeding requiring hospitalization
Time frame: Up to 20 years
Calculated results using a mimicked population
Number of intracranial hemorrhage (ICH)
Time frame: Up to 20 years
Calculated results using a mimicked population
Number of symptomatic peptic ulcers requiring hospitalization
Time frame: Up to 20 years
Calculated results using a mimicked population
Number of deaths due to any other cause
Time frame: Up to 20 years
Calculated results using a mimicked population
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Cardiovascular Disease, run by Bayer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of myocardial infarction and ischaemic stroke (time frame: Up to 20 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.