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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT03549260
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, 18 years of age or older
2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high risk for ASCVD based on AHA/ACC CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)
3. Body mass index (BMI) between 18 and 40 kg/m2
Exclusion Criteria:
1. Females of childbearing potential not using or willing to use an effective form of contraception, or pregnant or breastfeeding, or who have a positive serum pregnancy test at screening
2. Homozygous familial hypercholesterolemia
3. LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months
4. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
5. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
6. Newly diagnosed or poorly controlled (HbA1c \>9%) type 2 diabetes
7. Uncontrolled hypertension
8. Moderate to severe renal insufficiency
9. Elevated liver function test at screening
10. Uncontrolled cardiac arrhythmia or prolonged QT on EKG
11. A history of prescription drug abuse, illicit drug use, or alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03549260
Study Brief:
Protocol Section:
NCT03549260