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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Colorectal Cancer
• Intervention / Treatment: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

• Study Type: Observational
• Enrollment (Actual): 1028

Contacts and Locations

Study Locations

• Italy
  • Multiple Locations, Italy
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.; Other Names: Low-dose Aspirin
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); 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.; Other Names: Low-dose Aspirin
Physicians; Physicians from Italy with experience recommending low-dose aspirin for primary and/or secondary prevention of CVD and CRC.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Actual): October 14, 2019
• Study Completion (Actual): October 14, 2019

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Cardiovascular Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 20211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No