Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT03603366
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03603366
Study Brief:
Protocol Section:
NCT03603366