Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397657
Status:
TERMINATED
Last Update Posted:
2009-06-17
First Post:
2006-11-08
Brief Title:
Comparative Study of the Effect of Ezetimibe Versus Extended-Release Niacin on Atherosclerosis
Sponsor:
Walter Reed Army Medical Center
Organization:
Walter Reed Army Medical Center
Study Overview
Official Title:
ARBITER 6 ARterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6 - HDL and LDL Treatment Strategies in Atherosclerosis HALTS
Status:
TERMINATED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Independent steering committee has stopped the trial based on results of a prespecified blinded interim analysis It was not stopped due to safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of low-density lipoprotein LDL-C to provide greater protection from recurrent coronary heart disease CHD events Thus in August 2005 the guidelines for the treatment of lipid disorders NCEP ATPIII were revised to indicate that an LDL-C treatment goal of 70 mgdL revised from 100 mgdL was optional for patients with known CHD In these same guidelines low levels of high-density lipoprotein HDL-C are also suggested but not specifically proscribed as a target of therapy Recently the ARBITER 2 trial has provided the first evidence of the potential of raising HDL-C with extended release niacin when added to statin monotherapy However whether this approach would be superior to a strategy in which lower concentrations of LDL-C are targeted is unknown
The purpose of ARBITER 6 - HALTS is to compare HDL and LDL-focused strategies of lipid treatments for their effects of atherosclerosis This study is a prospective randomized open-label blinded endpoint trial comparing treatment strategies of either HDL-raising therapies or LDL reduction for dyslipidemia on carotid atherosclerosis Subjects with known atherosclerotic coronary or vascular disease or otherwise at high cardiovascular risk through the presence of a coronary risk equivalent who are currently being treated with a statin will be eligible Subjects will be randomly assigned in an allocation-concealed fashion to open label treatment with either Ezetimibe 10 mgd for additional LDL-lowering OR Extended-release niacin 1 gmd titrated to max tolerable dose up to 2 gmd for HDL improvement
The effects of these 2 different strategies of intensified lipid management on atherosclerosis will be assessed by the change in the carotid intima-media thickness a validated surrogate endpoint The data will help guide clinicians on the potential benefits of these lipid treatment strategies
The purpose of ARBITER 6 - HALTS is to compare HDL and LDL-focused strategies of lipid treatments for their effects of atherosclerosis This study is a prospective randomized open-label blinded endpoint trial comparing treatment strategies of either HDL-raising therapies or LDL reduction for dyslipidemia on carotid atherosclerosis Subjects with known atherosclerotic coronary or vascular disease or otherwise at high cardiovascular risk through the presence of a coronary risk equivalent who are currently being treated with a statin will be eligible Subjects will be randomly assigned in an allocation-concealed fashion to open label treatment with either Ezetimibe 10 mgd for additional LDL-lowering OR Extended-release niacin 1 gmd titrated to max tolerable dose up to 2 gmd for HDL improvement
The effects of these 2 different strategies of intensified lipid management on atherosclerosis will be assessed by the change in the carotid intima-media thickness a validated surrogate endpoint The data will help guide clinicians on the potential benefits of these lipid treatment strategies
Detailed Description:
None
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