Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoprotein(a)

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The trial is a randomized multicenter trial in Germany. Patients will be randomized to the apheresis group or to the control group. All patients will receive maximal risk minimizing therapies. The apheresis group will receive in addition weekly lipid apheresis. The principal outcome parameter is a composite endpoint of non-fatal myocardial infarction, interventional therapeutic procedure (PCI, stenting), coronary bypass surgery (CABG), non-fatal ischemic cerebrovascular accident, hospitalization due to acute coronary syndrome (ACS), critical limb ischemia, peripheral arterial revascularization procedure; amputation, death from cardiovascular cause.

Official Title
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Randomized Controlled Trial of Efficacy and Safety of Lipid Apheresis for the Prevention of Cardiovasc. Events in Patients With Progr. Cardiovasc. Disease, Lp(a)≥ 60 mg/dl and LDL-C <130 mg/dl on Maximally Tolerated Lipid-lowering Therapy

Conditions
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Hyperlipoproteinemia(a), Progressive Cardiovascular Disease

Intervention / Treatment
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* Procedure: Lipid apheresis
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipid apheresis<br>Lipid apheresis | Procedure: Lipid apheresis<br>* Weekly lipid apheresis procedure for lipoprotein(a) lowering<br>|
| Active Comparator: Standard care<br>Standard care | Other: Standard care<br>* Standard care for maximum cardiovascular risk reduction (behavioural, exercise, nutrition, drugs, etc.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Components of the primary endpoint considered individually |  | 5 years | 
| Death from any cause |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary heart disease, cerebrovascular disease, peripheral arterial disease, atherosclerosis, hyperlipoproteinemia