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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01064934
First Posted: February 9, 2010
Last Update Posted: June 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
  Purpose
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.

Condition Intervention
Hyperlipoproteinemia(a) Progressive Cardiovascular Disease Procedure: Lipid apheresis Other: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Components of the primary endpoint considered individually [ Time Frame: 5 years ]
  • Death from any cause [ Time Frame: 5 years ]

Enrollment: 0
Study Start Date: September 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lipid apheresis
Lipid apheresis
Procedure: Lipid apheresis
Weekly lipid apheresis procedure for lipoprotein(a) lowering
Active Comparator: Standard care
Standard care
Other: Standard care
Standard care for maximum cardiovascular risk reduction (behavioural, exercise, nutrition, drugs, etc.)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064934


Locations
Germany
Lipidambulanz, Interdisziplinäres Stoffwechsel-Centrum, CVK, Charite
Berlin, Germany, 13353
Sponsors and Collaborators
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
  More Information

Additional Information:
Responsible Party: Heiner K. Berthold, Professor, and Elisabeth Steinhagen-Thiessen, Professor, Charite University Medicine Berlin
ClinicalTrials.gov Identifier: NCT01064934     History of Changes
Other Study ID Numbers: ELAILa-01
First Submitted: February 8, 2010
First Posted: February 9, 2010
Last Update Posted: June 4, 2015
Last Verified: May 2010

Keywords provided by Charite University, Berlin, Germany:
coronary heart disease
cerebrovascular disease
peripheral arterial disease
atherosclerosis
hyperlipoproteinemia

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperlipoproteinemias
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases