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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT05325203
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent.
2. Males and females ≥ 18 to ≤ 80 years of age
3. DLCN\>8 in HeFH
4. Stable lipid-lowering therapies for at least 4 weeks
5. Patients with ASCVD LDL cholesterol≥1.4mmol/L at screening Patients without ASCVD LDL cholesterol≥2.6mmol/L at screening
6. Triglyceride≤4.5 mmol/L（400 mg/dL）;
Exclusion Criteria:
1. HoFH or meet the diagnostic criteria of HoFH
2. New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
3. History of uncontrolled arrhythmia within 90 days
4. Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 90 days of randomization
5. Planned cardiac surgery or revascularization.
6. Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
7. Uncontrolled hypertension.
8. Other conditions that the researchers considered inappropriate to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05325203
Study Brief:
Protocol Section:
NCT05325203