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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT03051360
Eligibility Criteria:
Inclusion Criteria:
1. The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
2. The patient has a working diagnosis of aortic stenosis (mild to moderate), and has fair treatment compliance.
Exclusion Criteria:
1. Age under 19 years old
2. Hypersensitivity to PCSK9 inhibitor
3. LDL cholesterol \< 70mg/dL at baseline
4. Poor treatement compliance (The patient will need to visit the out-patient clinic every 2-weeks for medication)
5. Positive pregnancy test or is known to be pregnant
6. Any other reason the investigator deems the subject to be unsuitable for the study (e.g., Active malignant tumor, Any life-threatening condition with life expectancy less than 6months, etc.)
7. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03051360
Study Brief:
Protocol Section:
NCT03051360