Clinical trial NCT03603366: 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
Official title: Patient-centred Benefit-risk Observational Study of Low-dose Aspirin for CVD (Cardiovascular Disease) and CRC (Colorectal Cancer) Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Colorectal Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 1028
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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

Primary outcomes:
measure: Perceive of low dose aspirin
timeFrame: Up to 1 hour
measure: Patients' benefit/risk trade-offs
timeFrame: Up to 1 hour
Secondary outcomes:
measure: Change in likelihood of AEs
timeFrame: Up to 1 hour
measure: Preferences of aspirin using in different subgroups
timeFrame: Up to 1 hour
Other outcomes:
Locations:
city: Multiple Locations
country: Italy
facility: Many locations
Study officials:
References: