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 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT06626659
Eligibility Criteria:
Inclusion Criteria:
1. Adults ≥18 years of age and ≤80 years of age who meet either of the following criteria:
1. Elevated Lp(a) (defined as greater than or equal to 100 nmol/L)
2. Non-elevated Lp(a) (defined as less than 100 nmol/L)
2. Willing and able to provide written informed consent and comply with study procedures.
Exclusion Criteria:
1. Unable or unwilling to provide written informed consent or provide a peripheral blood sample.
2. Any life-threatening disease expected to result in death within two years of consent.
3. Any malignancy not considered cured (except basal cell carcinoma of the skin). An individual is considered cured if there has been no evidence of cancer recurrence for the five years prior to screening.
4. Uncontrolled hypertension.
5. New York Heart Association Class IV heart failure.
6. Active liver disease or liver dysfunction.
7. Active kidney disease or kidney dysfunction.
8. History of hemorrhagic stroke or other major bleeding disorder.
9. White blood cell count ≥15 x 10\^9/L.
10. Women who are pregnant or nursing.
11. Previously received ribonucleic acid therapy specifically targeting Lp(a).
12. Active infectious disease requiring systemic antibiotic or anti-viral agents.
13. Known acquired immunodeficiency syndrome, such as human immunodeficiency virus.
14. On oral steroid therapy (e.g., prednisone or other corticosteroids) or other immunosuppressive agents (e.g., methotrexate).
15. Treated autoimmune disorders.
16. Participating in another study/trial that is likely to affect the primary outcome.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06626659
Study Brief:
Protocol Section:
NCT06626659