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

NCT ID: NCT01064934

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-08-31

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.

Conditions

Hyperlipoproteinemia(a); Progressive Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lipid apheresis

Lipid apheresis

Group Type: EXPERIMENTAL

Lipid apheresis

Intervention Type: PROCEDURE

Weekly lipid apheresis procedure for lipoprotein(a) lowering

Standard care

Standard care

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Standard care for maximum cardiovascular risk reduction (behavioural, exercise, nutrition, drugs, etc.)

Interventions

Lipid apheresis

Weekly lipid apheresis procedure for lipoprotein(a) lowering

Intervention Type: PROCEDURE

Standard care

Standard care for maximum cardiovascular risk reduction (behavioural, exercise, nutrition, drugs, etc.)

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Charite University Medicine Berlin

Principal Investigators

Heiner K. Berthold, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Elisabeth Steinhagen-Thiessen, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Lipidambulanz, Interdisziplinäres Stoffwechsel-Centrum, CVK, Charite

Berlin, , Germany

Countries

Germany

Other Identifiers

ELAILa-01

Identifier Type: -

Identifier Source: org_study_id