Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: ARBITER 6: ARterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6 - HDL and LDL Treatment Strategies in Atherosclerosis (HALTS)
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 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.


Options:
A: Arm Label: Placebo Q2W; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo to Evolocumab, Other: Placebo to Ezetimibe | Arm Label: Placebo QM; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo to Evolocumab, Other: Placebo to Ezetimibe | Arm Label: Ezetimibe (Q2W); Type: ACTIVE_COMPARATOR; Interventions: Drug: Ezetimibe, Biological: Placebo to Evolocumab | Arm Label: Ezetimibe (QM); Type: ACTIVE_COMPARATOR; Interventions: Drug: Ezetimibe, Biological: Placebo to Evolocumab | Arm Label: Evolocumab Q2W; Type: EXPERIMENTAL; Interventions: Biological: Evolocumab, Other: Placebo to Ezetimibe | Arm Label: Evolocumab QM; Type: EXPERIMENTAL; Interventions: Biological: Evolocumab, Other: Placebo to Ezetimibe | Intervention Type: BIOLOGICAL; Name: Evolocumab; Assigned to Arm(s): Evolocumab Q2W, Evolocumab QM | Intervention Type: DRUG; Name: Ezetimibe; Assigned to Arm(s): Ezetimibe (Q2W), Ezetimibe (QM) | Intervention Type: BIOLOGICAL; Name: Placebo to Evolocumab; Assigned to Arm(s): Ezetimibe (Q2W), Ezetimibe (QM), Placebo Q2W, Placebo QM | Intervention Type: OTHER; Name: Placebo to Ezetimibe; Assigned to Arm(s): Evolocumab Q2W, Evolocumab QM, Placebo Q2W, Placebo QM
B: Intervention Type: DRUG; Name: Fluvastatin; Assigned to Arm(s): N/A
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: simvastatin, Drug: atorvastatin | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: ezetimibe (+) simvastatin | Intervention Type: DRUG; Name: ezetimibe (+) simvastatin; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: simvastatin; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: atorvastatin; Assigned to Arm(s): 1
D: Arm Label: Extended release niacin; Type: ACTIVE_COMPARATOR; Interventions: Drug: extended release niacin, Drug: ezetimibe | Arm Label: Ezetimibe; Type: ACTIVE_COMPARATOR; Interventions: Drug: ezetimibe | Intervention Type: DRUG; Name: extended release niacin; Assigned to Arm(s): Extended release niacin | Intervention Type: DRUG; Name: ezetimibe; Assigned to Arm(s): Extended release niacin, Ezetimibe

Answer: D