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

This study is not yet open for participant recruitment.
Verified May 2010 by Charite University, Berlin, Germany
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01064934
First received: February 8, 2010
Last updated: May 25, 2010
Last verified: May 2010
History of Changes

February 8, 2010
May 25, 2010
September 2010
August 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01064934 on ClinicalTrials.gov Archive Site
  • Components of the primary endpoint considered individually [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Death from any cause [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoprotein(a)
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperlipoproteinemia(a)
  • Progressive Cardiovascular Disease
  • Procedure: Lipid apheresis
    Weekly lipid apheresis procedure for lipoprotein(a) lowering
  • Other: Standard care
    Standard care for maximum cardiovascular risk reduction (behavioural, exercise, nutrition, drugs, etc.)
  • Experimental: Lipid apheresis
    Lipid apheresis
    Intervention: Procedure: Lipid apheresis
  • Active Comparator: Standard care
    Standard care
    Intervention: Other: Standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
135
August 2015
August 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Adrian Rosada, MD +49 30 4594 ext 1934 elaila@egzb.de
Germany
 
NCT01064934
ELAILa-01
Yes
Heiner K. Berthold, Professor, and Elisabeth Steinhagen-Thiessen, Professor, Charite University Medicine Berlin
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Heiner K. Berthold, MD, PhD Charite University, Berlin, Germany
Principal Investigator: Elisabeth Steinhagen-Thiessen, MD Charite University, Berlin, Germany
Charite University, Berlin, Germany
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP