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

Bayer

Status: Completed

Conditions: Colorectal Cancer; Cardiovascular Disease

Treatments: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Study type: Observational

Funder types: Industry

Identifiers

NCT03603366

20211

Details and patient eligibility

About

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.

Enrollment: 1,028 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,028 participants in 3 patient groups

Primary prevention

Description:

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

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Secondary prevention

Description:

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

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Physicians

Description:

Physicians from Italy with experience recommending low-dose aspirin for primary and/or secondary prevention of CVD and CRC.