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

Not Applicable

Withdrawn

• Conditions: Hyperlipoproteinemia(a); Progressive Cardiovascular Disease
• Interventions: Procedure: Lipid apheresis; Other: Standard care

• Registration Number: NCT01064934
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Status Verified: 2010-05
• Study Start: 2010-09
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipid apheresis	Lipid apheresis	Lipid apheresis
Standard care	Standard care	Standard care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Components of the primary endpoint considered individually	5 years
Death from any cause	5 years

Trial Locations

Locations (1)

Lipidambulanz, Interdisziplinäres Stoffwechsel-Centrum, CVK, Charite; 🇩🇪 Berlin, Germany