check_circleStudy Completed

Cardiovascular Disease, Colorectal Cancer

Study to evaluate how patients regard the benefits and risks of low-dose aspirin for the prevention of heart and blood vessels disease and for the prevention of cancer of the colon and rectum

Trial purpose

Research shows that low-dose Aspirin prevents diseases of heart and blood vessels as well as cancer of the colon and rectum and it is also associated with risk of bleeding. In this study, they want to learn how patients regard the benefits and risks of low-dose Aspirin for the prevention of these diseases. The researchers also want to learn how patients balance these risks and benefits.

Key Participants Requirements

Sex

All

Age

18 - 70 Years

Trial summary

Enrollment Goal
1028
Trial Dates
August 2019 - October 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Italy

Primary Outcome

  • Perceive of low dose aspirin
    Using qualitative interviews to assess how patients and physicians perceive the benefits and risks of low-dose aspirin for the prevention of cardiovascular disease (CVD) and colorectal cancer (CRC)
    date_rangeTime Frame:
    Up to 1 hour
  • Patients' benefit/risk trade-offs
    Using quantitative surveys to elicit patients’ benefit/risk trade-offs on key efficacy and safety outcomes of low-dose aspirin in CVD and CRC prevention
    date_rangeTime Frame:
    Up to 1 hour

Secondary Outcome

  • Change in likelihood of AEs
    Quantify the change in likelihood of adverse events (AEs) that patients are willing to accept in order to experience the benefits of low-dose aspirin for CRC and CVD prevention compared to CVD prevention alone
    date_rangeTime Frame:
    Up to 1 hour
  • Preferences of aspirin using in different subgroups
    Assess how different subgroups of patients, such as those using low-dose aspirin and those eligible for but not using low-dose aspirin, differ in their preferences
    date_rangeTime Frame:
    Up to 1 hour

Trial design

Patient-centred Benefit-risk Observational Study of Low-dose Aspirin for CVD (cardiovascular disease) and CRC (colorectal cancer) Prevention
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A