Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoprotein(a) (NCT01064934) | Clinical Trial Compass
WithdrawnNot Applicable
Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoprotein(a)
Germany0Started 2010-09
Plain-language summary
Lipoprotein(a) \[Lp(a)\] is an independent risk factor for cardiovascular disease. Non-medical treatment measures (e.g. dietary therapy or weight loss) can hardly influence Lp(a) plasma concentrations. Drug therapy has only limited influence, e.g. treatment with niacin. Statins are usually without effect. Lipid apheresis is the only treatment known to lower elevated Lp(a) levels in a relevant way. In patients with pronounced elevation of Lp(a) and normal LDL cholesterol levels, who suffer from progressive cardiovascular disease, the treatment with lipid apheresis seems to be a last-resort treatment option. The current trial will evaluate the effectiveness of lipid apheresis on cardioavascular endpoints.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Above 18 years of age
* Male or female
* Written informed consent
* Lipoprotein(a) \>=60 mg/dL
* Low-density lipoprotein cholesterol \<130 mg/dL
* Progressive cardiovascular disease
* Positive recommendation by the Inclusion Committee
Exclusion Criteria:
* Current participation in a lipid apheresis program
* Previous participation in a lipid apheresis program
* Low-density lipoprotein cholesterol \>=130 mg/dL under maximally tolerated (or necessary) drug treatment
* Triglyceride concentrations \>=450 mg/dL
* Known homozygous familial hypercholesterolemia
* Known type III hyperlipoproteinemia
* Pregnancy, breast feeding
* History of malignant disease (with the exception of non-melanoma carcinomas of the skin and carcinoma in situ of the cervix)
* Planned major surgical procedures in the next 3 months
* Current participation in another interventional trial
* Previous randomization in the current trial (applies only for the RCT)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite endpoint, defined as first occurrence of one of the following: myocardial infarction, interventional therapeutic procedure, CABG, cerebrovascular accident, hospitalization due to ACS, periph. art. revasc., death from cardiovascular cause