Comparative Study of the Effect of Ezetimibe Versus Extended-Release

Status Terminated

Clinical Trial 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 mg/dL (revised from 100 mg/dL) 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 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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Atherosclerosis

Clinical Trial Details

NCT number	NCT00397657
Study type	Interventional
Source	Walter Reed Army Medical Center
Contact
Status	Terminated
Phase	Phase 4
Start date	November 2006
Completion date	October 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05052918` - The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes	N/A
Recruiting	`NCT04511234` - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease	N/A
Completed	`NCT05906797` - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.	N/A
Completed	`NCT03273972` - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers	N/A
Suspended	`NCT02932176` - Machine Learning for Handheld Vascular Studies
Recruiting	`NCT05158257` - Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity	N/A
Completed	`NCT01212900` - Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression	Phase 4
Completed	`NCT03697382` - Effect of Daily Steps on Fat Metabolism	N/A
Recruiting	`NCT06230406` - T-Mem GEne in Atherosclerosis
Completed	`NCT03654313` - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus	Phase 1
Completed	`NCT00382564` - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease	N/A
Recruiting	`NCT02894931` - Effects of Dietary Interventions on Serum and Macrophage Atherogenicity	N/A
Not yet recruiting	`NCT02578355` - National Plaque Registry and Database	N/A
Completed	`NCT02998918` - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL	N/A
Recruiting	`NCT02265250` - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Completed	`NCT02224339` - New Technologies to Determine Carotid Plaque Vulnerability
Completed	`NCT02268513` - Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
Completed	`NCT03393377` - Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination	N/A
Completed	`NCT02377310` - Pd/Pa vs iFR™ in an Unselected Population Referred for Invasive Angiography	N/A
Not yet recruiting	`NCT01923012` - Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparative Study of the Effect of Ezetimibe Versus Extended-Release Niacin on Atherosclerosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms