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

Study Overview
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Brief Summary
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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.

Official Title
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Patient-centred Benefit-risk Observational Study of Low-dose Aspirin for CVD (Cardiovascular Disease) and CRC (Colorectal Cancer) Prevention

Conditions
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Cardiovascular Disease, Colorectal Cancer

Intervention / Treatment
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* Drug: Acetylsalicylic acid (Aspirin, BAYE4465)


Participation Criteria
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Eligibility Criteria
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Patient Eligibility Criteria Inclusion 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary prevention<br>Patients in Italy who are eligible to use low-dose aspirin for primary prevention of CVD and CRC. Subgroups: Patients eligible for and using low-dose aspirin who are at 20% ten-year CVD risk for primary prevention of CVD Patients eligible for and not using low-dose aspirin who are at 20% ten-year CVD risk for primary prevention of CVD | Drug: Acetylsalicylic acid (Aspirin, BAYE4465)<br>* This study does not involve prescription of the drugs. This study is a cross-sectional survey of patients taking low-dose aspirin or patients who are eligible but not taking low-dose aspirin.<br>* Other names: Low-dose Aspirin;|
| Secondary prevention<br>Patients in Italy who are eligible to use low-dose aspirin for secondary prevention of CVD and CRC. Subgroups: Patients eligible for and using low-dose aspirin for secondary prevention of CVD Patients eligible for and not using low-dose aspirin for secondary prevention of CVD | Drug: Acetylsalicylic acid (Aspirin, BAYE4465)<br>* This study does not involve prescription of the drugs. This study is a cross-sectional survey of patients taking low-dose aspirin or patients who are eligible but not taking low-dose aspirin.<br>* Other names: Low-dose Aspirin;|
| Physicians<br>Physicians from Italy with experience recommending low-dose aspirin for primary and/or secondary prevention of CVD and CRC. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | Up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Up to 1 hour |