Clinical trial NCT01064934: Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoprotein(a)
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hyperlipoproteinemia(a)
Progressive Cardiovascular Disease
Keywords: coronary heart disease
cerebrovascular disease
peripheral arterial disease
atherosclerosis
hyperlipoproteinemia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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)

Primary outcomes:
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
timeFrame: 5 years
Secondary outcomes:
measure: Components of the primary endpoint considered individually
timeFrame: 5 years
measure: Death from any cause
timeFrame: 5 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Lipidambulanz, Interdisziplinäres Stoffwechsel-Centrum, CVK, Charite
Study officials:
affiliation: Charite University, Berlin, Germany
name: Heiner K. Berthold, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Elisabeth Steinhagen-Thiessen, MD
role: PRINCIPAL_INVESTIGATOR
References: