Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01064934
Status:
WITHDRAWN
Last Update Posted:
2015-06-04
First Post:
2010-02-08
Brief Title:
Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoproteina
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
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 Lpa 60 mgdl and LDL-C 130 mgdl 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WITHDRAWN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:
Lipoproteina Lpa is an independent risk factor for cardiovascular disease Non-medical treatment measures eg dietary therapy or weight loss can hardly influence Lpa plasma concentrations Drug therapy has only limited influence eg treatment with niacin Statins are usually without effect Lipid apheresis is the only treatment known to lower elevated Lpa levels in a relevant way In patients with pronounced elevation of Lpa 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:
Lipoproteina Lpa is an independent risk factor for cardiovascular disease Non-medical treatment measures eg dietary therapy or weight loss can hardly influence Lpa plasma concentrations Drug therapy has only limited influence eg treatment with niacin Statins are usually without effect Lipid apheresis is the only treatment known to lower elevated Lpa levels in a relevant way In patients with pronounced elevation of Lpa 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:
None
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?:
None