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
  • Patient Eligibility Criteria

    :
    - Age and CVD characteristics
     -- Primary prevention:
     --- 50-70 years of age
     --- Self-report clinical characteristics that result to 20% or higher, 10-year risk of CVD based on the Progetto Cuore scores
     -- Secondary prevention:
     --- 18 years or older
     --- Having a self-reported history of CV event (e.g., myocardial infarction (MI), ischaemic stroke or Transient Ischaemic stroke, , and angina)
    - Able to read and understand Italian
    - No participation in an investigational program with interventions outside of routine clinical practice
    - For qualitative interviews:
     -- Willing and able to provide (electronic) informed consent to participate in the study
     -- Willing and able to participate in a telephone interview, and to be audio-recorded
    - For pilot/cognitive interviews :
     -- Willing and able to complete an online survey
     -- Willing and able to provide (electronic) informed consent to participate in the study
     -- Willing and able to participate in an in-person interview, and to be audio-recorded
    - For quantitative main survey:
     -- Willing and able to complete an online survey
     -- Willing and able to provide (electronic) informed consent to participate in the study
  • - Have glucose-6-phosphate dehydrogenase (G6PD) deficiency (which commonly causes haemolytic anaemia, which is often triggered from eating fava beans, a condition called Favism)
    - Have the following conditions (which are contraindications to low-dose aspirin)
     -- Known hypersensitivity to salicylates
     -- Known to have had asthma induced by salicylates
     -- Having been diagnosed with acute gastroduodenal ulcers
     -- Haemorrhagic diathesis
     -- Renal failure
     -- Hepatic failure
    - Concomitant treatment with methotrexate
    - Cognitive impairment, hearing difficulty, visual impairment, acute psychopathology, or insufficient knowledge of Italian that—in the opinion of the investigator/interviewer—could interfere with a patient’s ability to provide written consent and complete an interview or survey
    - To be currently pregnant
    - Are pharmaceutical company employees or employed in a position where they have a direct role in treating patients with CVD

    Physician Eligibility Criteria:

    - A medically trained physician
    - Able to read, speak, and understand Italian sufficiently to complete an interview
    - Able to provide informed consent electronically
    - Have at least five year experience prescribing low-dose aspirin for primary and secondary prevention of CVD
    - Willing to be audio-recorded, including adherence to the interview instructions

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