Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 251 for:    ASPIRIN AND low-dose aspirin

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03904732
Recruitment Status : Active, not recruiting
First Posted : April 5, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment
Colorectal Cancer Cardiovascular Disease Bleeding 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000000 participants
Observational Model: Other
Time Perspective: Other
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
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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



Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904732


Locations
Layout table for location information
United Kingdom
Mimicked population
Mimicked Population, United Kingdom
Sponsors and Collaborators
Bayer

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03904732     History of Changes
Other Study ID Numbers: 20751
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Colorectal Neoplasms
Cardiovascular Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics