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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02791802
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 - 70
2. Male or female
3. Written informed consent
4. Lipoprotein(a) \> 60 mg/dL, or \> 120 nmol/L using an alternative laboratory method
5. Corrected Low-density lipoprotein cholesterol \< 100 mg/dL (2.6 mmol/l) during 3 months prior to study enrolment.
6. Established cardiovascular disease with disease progression indicated by one major cardiovascular event, which might be either
* myocardial infarction
* PCI
* CABG
* Stroke
* or revascularization of peripheral arteries using PTA, stenting or bypass surgery
(with or without subsequent cardiovascular events/interventions) despite adequately controlled cardiovascular risk factors\* occuring within the last 2 years prior to enrolment
(\*Hypertension, Diabetes, tobacco consumption, LDL Cholesterol)
7. Platelet aggregation inhibitors or systemic anticoagulation according to cardiologic indication
8. Positive recommendation by central Trial Expert Committee
Exclusion Criteria:
1. Previous lipoprotein apheresis therapy
2. Triglyceride concentrations ≥ 250 mg/dL (2.8 mmol/L)
3. Known homozygous or compound heterozygous familial hypercholesterolemia
4. Known type III hyperlipoproteinemia
5. Pregnancy, breast feeding
6. Active smoking, defined as any inhaled tobacco consumption with in the last 3 months
7. Uncontrolled hypertension (\>160/90 mmHg)
8. Active malignant disease
9. Planned major surgical procedures
10. Current participation in an interventional trial
11. Contraindication for apheresis therapy (e. g. necessity of ACE inhibitor therapy)
12. CKD stages IV and V
13. Diabetes mellitus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02791802
Study Brief:
Protocol Section:
NCT02791802