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

Hyperlipoproteinemia(a) Clinical Trial

— ELAILa  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01064934
• Other study ID #: ELAILa-01
• Status: Withdrawn
• Phase: N/A
• First received: February 8, 2010
• Last updated: June 3, 2015
• Start date: September 2010
• Est. completion date: August 2015

Study information

• Verified date: May 2010
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hyperlipoproteinemia(a)
• Hyperlipoproteinemias
• Progressive Cardiovascular Disease

Intervention

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.)

Locations

Country	Name	City	State
Germany	Lipidambulanz, Interdisziplinäres Stoffwechsel-Centrum, CVK, Charite	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		5 years	Yes
Secondary	Components of the primary endpoint considered individually		5 years	Yes
Secondary	Death from any cause		5 years	Yes

External Links

•   Official study website