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

NCT01064934 | Withdrawn DMC

• 1 other identifier: ELAILa-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipoproteinemia(a); Progressive Cardiovascular Disease

Keywords

coronary heart disease; cerebrovascular disease; peripheral arterial disease; atherosclerosis; hyperlipoproteinemia

Outcome Measures

Primary Outcomes (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

  5 years

Secondary Outcomes (2)

• Components of the primary endpoint considered individually

  5 years

• Death from any cause

  5 years

Study Arms (2)

Lipid apheresis

EXPERIMENTAL

Lipid apheresis

Procedure: Lipid apheresis

Standard care

ACTIVE COMPARATOR

Standard care

Other: Standard care

Interventions

Lipid apheresis PROCEDURE

Weekly lipid apheresis procedure for lipoprotein(a) lowering

Lipid apheresis

Standard care OTHER

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

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Lipidambulanz, Interdisziplinäres Stoffwechsel-Centrum, CVK, Charite

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Coronary Disease; Cerebrovascular Disorders; Peripheral Arterial Disease; Atherosclerosis; Hyperlipoproteinemias

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Heiner K. Berthold, MD, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Elisabeth Steinhagen-Thiessen, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 4, 2015

Record last verified: 2010-05

Locations

DE (1)