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:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT06456658
Eligibility Criteria:
Inclusion Criteria:
* Patients between the ages of 18 and 75
* Seen in primary care visit within Vanderbilt University Medical Center
* Eligible for statin therapy due to 1) Atherosclerotic cardiovascular disease (ASCVD) 10- year risk greater than or equal to 10%, 2) Type 1 or 2 diabetes and aged 40 years or older, or 3) ASCVD diagnosis
Exclusion Criteria:
* Already on statin, ezetimibe, bempedoic acid, or PCSK9 inhibitor
* Last low-density lipoprotein cholesterol (LDL-C) less than 100 mg/dL
* Pregnant or lactating
* Palliative care
* Statin allergy or adverse effect of statin
* Rhabdomyolysis
* Statin contraindicated due to liver disease, defined as 1) Decompensated liver disease, 2) AST or ALT greater than 5 times the upper limit of normal, or 3) Total bilirubin greater than 1.5 mg/dL
* Statin contraindicated due to kidney disease, defined as 1) Dialysis or 2) Estimated glomerular filtration rate less than 15 ml/min/1.73m\^2
* Has had coronary calcium computerized tomography
* Less than 3 months since lipid panel resulted
* Acute visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06456658
Study Brief:
Protocol Section:
NCT06456658