WithdrawnNot Applicable

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

Germany0Started 2010-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Timeframe: 5 years

Trial details

NCT IDNCT01064934

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-08