Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-01-01 @ 5:55 AM
Study NCT ID:
NCT01064934
Status:
WITHDRAWN
Last Update Posted:
2015-06-04
First Post:
2010-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoprotein(a)
Sponsor:
Charite University, Berlin, Germany
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELAILa
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: