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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07460960
Eligibility Criteria:
Inclusion Criteria:
* male patients aged 40-65 years, sexually active
* high and very high risk of cardiovascular events (The Systematic Coronary Risk Evaluation 2 (SCORE2))
* absence of previous statin therapy for 3 months
* there are no known cardiovascular diseases requiring the appointment of statins in high doses from the start of treatment
* the invariance of concomitant therapy for 3 months, if the patient needs it.
Exclusion Criteria:
* known statin intolerance
* known hypogonadism
* persistent forms of atrial fibrillation
* active malignant neoplasm requiring treatment at the time of screening
* known chronic inflammatory diseases (rheumatoid arthritis, systemic connective tissue diseases, metabolically associated fatty liver disease, etc.)
* impaired renal function (estimated glomerular filtration rate \<30 ml/min/1.73 m2) and liver (transaminase levels more than 3 times reference values, bilirubin levels more than 2 times reference values)
* chronic heart failure
* a well-known diagnosis of mental illness
* alcoholism and drug addiction
* glucocorticoid therapy and regular therapy with nonsteroidal anti-inflammatory drugs (80% of the time for 3 months before switching on)
* participation in any other clinical trial during this trial, including participation in the trial for 30 days prior to providing informed consent
* the patient's inability to understand the essence of the study and consent to participate in it
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT07460960
Study Brief:
Protocol Section:
NCT07460960