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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT05066932
Eligibility Criteria:
Inclusion Criteria:
A. Patients with familial hypercholesterolemia (FH) and with hyperTG :
1. Age \> 18 years
2. Molecular or clinical diagnosis of FH
3. Primary prevention (no coronary artery disease, cerebrovascular disease or lower limb arterial disease)
4. HyperTG or TG levels between 135-500 mg/dl on statin therapy
5. Patient informed of the research, not having objected to participation and having provided written consent for genetic analysis
B. Patients with familial hypercholesterolemia (FH) and without hyperTG :
1. Age \> 18 years
2. Mild diagnosis
3. Primary prevention (no coronary artery disease, cerebrovascular disease or lower limb arterial disease)
4. TG \<135mg/dl on statin therapy
5. Patient informed of the research, did not object to participation and provided written consent for genetic testing
Exclusion Criteria:
1. Secondary prevention or planned coronary intervention or cardiac surgery
2. History of acute or chronic pancreatitis
3. Statin-intolerant patient
4. Glycated haemoglobin level greater than 10.0%.
5. Human Immunodeficiency Virus infection on treatment,
6. Use of corticosteroids
7. Severe renal impairment (Glomerular filtration rate \< 30 ml/min)
8. Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05066932
Study Brief:
Protocol Section:
NCT05066932