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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603366
• Other study ID #: 20211
• Status: Completed
• Start date: August 14, 2019
• Est. completion date: October 14, 2019

Study information

• Verified date: September 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1028
• Est. completion date: October 14, 2019
• Est. primary completion date: October 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Acetylsalicylic acid (Aspirin, BAYE4465)
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.

Locations

Country	Name	City	State
Italy	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

External Links

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