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

NCT03603366 | Completed

• 1 other identifier: 20211
• Study Type: observational
• Target: 1,028
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Disease; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in likelihood of AEs

  Up to 1 hour

• Preferences of aspirin using in different subgroups

  Up to 1 hour

Study Arms (3)

Primary prevention

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)

Secondary prevention

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)

Physicians

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

Interventions

Acetylsalicylic acid (Aspirin, BAYE4465) DRUG

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.

Also known as: Low-dose Aspirin

Primary prevention; Secondary prevention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age and CVD characteristics
• Primary prevention:
• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Italy

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Cardiovascular Diseases; Colorectal Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 27, 2018
• Study Start: August 14, 2019
• Primary Completion: October 14, 2019
• Study Completion: October 14, 2019
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

IT (1)