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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hyperlipoproteinemia(a); Progressive Cardiovascular Disease
• Intervention / Treatment: Procedure: Lipid apheresis; Other: Standard care

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Lipidambulanz, Interdisziplinäres Stoffwechsel-Centrum, CVK, Charite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Heiner K. Berthold, MD, PhD, Charite University, Berlin, Germany; Principal Investigator: Elisabeth Steinhagen-Thiessen, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: February 8, 2010
• First Submitted That Met QC Criteria: February 8, 2010
• First Posted (Estimate): February 9, 2010

Study Record Updates

• Last Update Posted (Estimate): June 4, 2015
• Last Update Submitted That Met QC Criteria: June 3, 2015
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: atherosclerosis; peripheral arterial disease; coronary heart disease; cerebrovascular disease; hyperlipoproteinemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Cardiovascular Diseases; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: ELAILa-01