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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT02537535
Eligibility Criteria:
Inclusion Criteria:
1\. Adults ≥ 18 years old 2. High risk for cardiovascular morbidity and mortality (at least one of the following):
1. Clinical vascular disease:
* Coronary Artery Disease (CAD): history of myocardial infarction (MI), Coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), angiographic disease
* Cerebrovascular Disease (CeVD): history of cerebrovascular accident (CVA) or transient ischemic attack (TIA), carotid surgery
* Abdominal Aortic Aneurism (AAA): history of surgery/intervention
* Peripheral Arterial Disease (PAD): history of surgery/intervention
2. Familial hypercholesterolemia defined as LDL-C \> 5 mmol/L and one of:
* typical physical findings (stigmata) such as tendon xanthomata, xanthelasma, and arcus corneae
* personal history of early cardiovascular disease
* family history of early cardiovascular disease or of marked hyperlipidemia
3. Receiving current optimal (maximal or maximal tolerated) statin therapy for at least 3 months prior to patient enrolment
4. LDL-C \> 2.0 mmol/L measured within 6 months of patient enrolment date and while on (despite) maximal tolerated statin therapy (± other lipid modifying therapies).
5. Desire and ability to execute the consent to participate.
Exclusion criteria:
1. Current treatment with PCSK9 inhibitor
2. Participation in an investigational study
3. Prior participation in the GOAL program
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02537535
Study Brief:
Protocol Section:
NCT02537535