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.

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

Adult patients who are eligible for and/or taking low-dose aspirin will be recruited for qualitative interviews, pilot/cognitive interviews, and the main quantitative survey. Medically trained physicians who have experience prescribing low-dose aspirin for CVD (cardiovascular disease) and CRC (colorectal cancer) prevention will be eligible for the qualitative interviews.

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.