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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT06542432
Eligibility Criteria:
Inclusion Criteria:
* ASCVD risk ≥5% and below 20% over the following 10 years as defined by the standard pooled cohort equations
* No previous CAD event (inclusive of myocardial infarction, diagnosis of CAD, stroke)
* Previously genotyped as part of a research study that enables recontact of participants
* Receiving primary care at a participating institution.
Exclusion Criteria:
* Prior diagnosis of CAD: inclusive of prior myocardial infarction and revascularization (stent or coronary artery bypass grafting)
* Currently treated with lipid-lowering therapy, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, or bempedoic acid
* Future use of statins contraindicated
* Prior diagnosis of Cerebrovascular disease: Inclusive of history of ischemic stroke, transient ischaemic attack (TIA), carotid endarterectomy, carotid artery stenting
* Prior diagnosis of Peripheral arterial disease: Inclusive of history of claudication, revascularization (stents or bypass)
* Severe hypercholesterolemia (LDL-C ≥ 190 mg/dL)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT06542432
Study Brief:
Protocol Section:
NCT06542432