Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Walter Reed Army Medical Center Kos Pharmaceuticals |
---|---|
Information provided by: | Walter Reed Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00397657 |
Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of 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 mg/dL (revised from 100 mg/dL) was optional for patients with known CHD. In these same guidelines, low levels of 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 mg/d for additional LDL-lowering OR Extended-release niacin ( 1 gm/d, titrated to max tolerable dose up to 2 gm/d)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.
Condition | Intervention | Phase |
---|---|---|
Atherosclerosis |
Drug: extended release niacin Drug: ezetimibe |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 400 |
Study Start Date: | November 2006 |
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Allen J Taylor, MD | 202-782-2887 | allen.taylor@na.amedd.army.mil |
Contact: Patrick J Devine, MD | 202-782-9855 | patrick.devine@na.amedd.army.mil |
United States, District of Columbia | |
Walter Reed Army Medical Center | Recruiting |
Washington, District of Columbia, United States, 20307 | |
Contact: Kimmi Novak, RN 202-782-9861 kim.novak@na.amedd.army.mil | |
Contact: Patrick J Devine, MD 202-782-9855 patrick.devine@na.amedd.army.mil | |
Principal Investigator: Allen J Taylor, MD | |
Sub-Investigator: Patrick J Devine, MD | |
United States, Maryland | |
Washington Adventist Hospital | Recruiting |
Takoma Park, Maryland, United States, 20912 | |
Contact: Dawn E. Shaddinger, RN, MSN, CCRN 301-891-5612 dshaddin@ahm.com | |
Principal Investigator: Mark A Turco, MD |
Principal Investigator: | Allen J Taylor, MD | Walter Reed Army Medical Center |
Study ID Numbers: | 06-12027 |
Study First Received: | November 8, 2006 |
Last Updated: | September 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00397657 |
Health Authority: | United States: Federal Government |
carotid intima media thickness atherosclerosis niacin |
coronary heart disease HDL-C LDL-C |
Arterial Occlusive Diseases Coronary Disease Atherosclerosis Nicotinic Acids Heart Diseases |
Vascular Diseases Ezetimibe Arteriosclerosis Niacin Coronary Artery Disease |
Antimetabolites Vasodilator Agents Vitamin B Complex Molecular Mechanisms of Pharmacological Action Antilipemic Agents Growth Substances Physiological Effects of Drugs |
Anticholesteremic Agents Cardiovascular Agents Pharmacologic Actions Therapeutic Uses Vitamins Cardiovascular Diseases Micronutrients |