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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 135
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064934

Contacts
Contact: Adrian Rosada, MD +49 30 4594 ext 1934 elaila@egzb.de

Locations
Germany
Lipidambulanz, Interdisziplinäres Stoffwechsel-Centrum, CVK, Charite Not yet recruiting
Berlin, Germany, 13353
Principal Investigator: Elisabeth Steinhagen-Thiessen, MD            
Sub-Investigator: Ursula Kassner, MD            
Sub-Investigator: Eleni Giannakidou, MD            
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:
Official study website  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: February 8, 2010
Last Updated: May 25, 2010
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013