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

NCT01064934 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-06-04

No results posted yet for this study

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

Interventions

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.)

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Heiner K. Berthold, MD, PhD · Charite University, Berlin, Germany

  • Elisabeth Steinhagen-Thiessen, MD · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01064934 on ClinicalTrials.gov